In 2016, the cumulative worldwide volume of the the following CVD procedures is projected to approach 15.05 million surgical and transcatheter interventions:
roughly 4.73 million coronary revascularization procedures via CABG and PCI (or about 31.4% of the total),
close to 4 million percutaneous and surgical peripheral artery revascularization procedures (or 26.5% of the total);
about 2.12 million cardiac rhythm management procedures via implantable pulse generator placement and arrhythmia ablation (or 14.1% of the total);
over 1.65 million CVI, DVT, and PE targeting venous interventions (representing 11.0% of the total);
more than 992 thousand surgical and transcatheter heart defect repairs and valvular interventions (or 6.6% of the total);
close to 931 thousand acute stroke prophylaxis and treatment procedures (contributing 6.2% of the total);
over 374 thousand abdominal and thoracic aortic aneurysm endovascular and surgical repairs (or 2.5% of the total); and
almost 254 thousand placements of temporary and permanent mechanical cardiac support devices in bridge to recovery, bridge to transplant, and destination therapy indications (accounting for about 1.7% of total procedure volume).
Coronary artery bypass grafting (CABG) is the most common type of cardiovascular surgical intervention, which “bypasses” acute or chronic coronary artery obstructions via a newly created vascular conduit and thus reinstate normal or sufficient blood flow to the ischemic but still viable areas of the myocardium.
The majority of CABG surgeries (up to 75%) are still performed on the fully arrested heart which is accessed via a foot-long incision over the sternum and completely separated patient’s rib cage. Following a full sternotomy, the CABG patient is typically placed on extracorporeal cardiopulmonary bypass (CPB) with a heart-lung machine, which allows the surgeon to operate on a still and bloodless field. Simultaneously, the patient’s greater saphenous vein or internal mammary artery, or both are harvested (mobilized) for use as a bypass conduit in the ongoing procedure. Depending on the location, character and number of the coronary artery occlusions, the surgery might involve between one and seven coronary bypasses.
Once the bypasses are completed, the heart is restarted and, if it functions normally, the patient is removed from the heart-lung machine and the chest is closed up, the sternum is stabilized with stainless steel wire, and the chest and leg wounds are closed with sutures or clips. Patient’s recovery from a routine uncomplicated CABG usually involves seven to ten days of hospital stay, including two to three days spent in the cardiac intensive care unit.
Less Invasive CABG
Over the past decade, several less-invasive versions of the CABG were developed with the view of reducing morbidity and potentially serious complications associated with extensive surgical trauma and the use of aortic clamping and CPB. The current arsenal of less-invasive coronary artery bypass techniques includes minimally-invasive direct CABG (MIDCAB), full-sternotomy “off-pump” CABG (OPCAB), port-access CABG (P-CAB) with peripheral cannulation and endoclamping of aorta, and endoscopic computer (robotics)-assisted CABG (C-CAB).
Designed to limit surgical trauma of conventional CABG, the MIDCAB procedure is best suited for patients with occluding lesions either in the left anterior descending (LAD) artery, or the right coronary artery (RCA). In contrast to conventional CABG, it is performed on a beating heart without the use of CPB. In MIDCAB surgery, access to targeted arteries is achieved through a limited left anterior thoracotomy in the case of occluded LAD, and right thoracotomy or limited lateral thoracotomy in cases involving diseased proximal RCA or circumflex artery. Because of the smaller surgical trauma and off-pump performance (without aorta clamping), the MIDCAB procedure typically results in fewer complications, lower morbidity and shorter hospital stays compared to conventional CABG. However, its utility is limited to a subset of patients with one or two coronary vascular targets, which constitute a small fraction (<3%) of the total caseloads referred for CABG.
The OPCAB procedure is performed on a beating heart after reduction of cardiac motion with a variety of pharmacological and mechanical devices. These include slowing the heart rate with ß-blockers and calcium channel blockers and the use of special mechanical devices intended to stabilize the myocardium and mobilize target vessels. The use of various retraction techniques allows to gain access to vessels on the lateral and inferior surfaces of the heart. Because the OPCAB technique also involves surgical access via median sternotomy, its primary benefit is the avoidance of complications resulting from the use of cardiopulmonary bypass, not surgical trauma.
Over the past decade, the OPCAB surgery emerged as the most popular form of less-invasive coronary artery bypass procedures in the U.S, and Western Europe. By the beginning of this decade, an estimated 25% of all CABGs performed in these geographies were done without the use of CPB. However, in recent years, the relative usage of OPCAB techniques remained largely unchanged. In the view of many cardiac surgeons, the latter was predicated by the increasing morphological complexity of cases referred for CABG (rather than PCI) and generally superior immediate and longer-term bypass graft patency and patient outcomes obtainable with technically less-demanding on-pump CABG surgery.
In contrast to that, the relative usage of “neurological complications sparing” OPCAB techniques is significantly higher in major Asia-Pacific states reaching over 60% of all CABG procedures in China, India, and Japan.
The rarely used P-CAB procedure involves the use of cardiopulmonary bypass and cardioplegia of a globally arrested heart. Vascular access for CPB is achieved via the femoral artery and vein. Compared to the MIDCAB technique, the use of multiple ports allow access to different areas of the heart, thus facilitating more complete revascularization, and the motionless heart may allow a more accurate and reliable anastomosis. In distinction from conventional CABG, median sternotomy is avoided, which reduces trauma and complications. However, potential morbidity of the port-access operation includes multiple wounds at port sites, the limited thoracotomy, and the groin dissection for femoral-femoral bypass. The procedure is also technically difficult and time consuming and therefore has not achieved widespread popularity.
The Hybrid CABG-PCI procedure combines the use of surgical bypass (typically MIDCAB) and percutaneous coronary interventional techniques (angioplasty and stenting) for optimal management of multi-vessel coronary occlusions in high risk patients. The main rationale behind the utilization of hybrid procedure is to achieve maximally possible myocardial revascularization with minimally possible trauma and reduced probability of post-procedural complications. The most common variation of the hybrid revascularization involves MIDCAB-based radial anastomosis between the left anterior descending artery and left internal thoracic artery accompanied by the PTCA/stenting-based recanalization of less critical coronary artery occlusions.
CABG Utilization Trends and Procedure Volumes
Since the advent of coronary angioplasty in the late 1970s, the relative role and share of CABG procedures in myocardial revascularization have been steadily declining due to a continuing penetration of treated patient caseloads by a less invasive PTCA. This general trend was further expedited by the advent of coronary stents. At the very end of the past decade, the rate of transition towards percutaneous coronary interventions in myocardial revascularization started tapering off, primarily due to growing maturity of PTCA/stenting technology and nearly full coverage of patient caseloads with one- or uncomplicated two-vessel disease amendable through angioplasty and stenting. At the same time, a growing popularity of the less-invasive CABG regimens resulted in some additional influx into CABG caseloads from a no-option patient cohort. A less-invasive surgical coronary bypass also emerged as a preferred treatment option for some gray-area patients that were previously referred for sub-optimal PTCA and stenting to avoid potential complications of conventional CABG.
In 2006 – for the first time in about two decades – the U.S. and European volumes of CABG procedures experienced a visible increase, which was repeated in 2007 and reproduced on a smaller and diminishing scale in the following two years.
The cited unexpected reversal of a long established downward procedural trend reflected an acute (and, probably, somewhat overblown) end-users’ concern about long-term safety (AMI-prone late thrombosis) of drug-eluting stents (DES), which prompted a steep decline in utilization of DES in 2006, 2007, followed by a smaller and tapering decreases in 2008 and 2009 with corresponding migration of advanced CHD patients referred for radical intervention to bare metal stenting and CABG surgery.
In 2010 – 2015 the volume of CABG surgeries remained relatively unchanged, notwithstanding a visible decline in percutaneous coronary interventions and overall myocardial revascularization procedures.
In the forthcoming years, the cumulative global volume of CABG procedures is unlikely to experience any significant changes, while their relative share in coronary revascularization can be expected to decline from about 15.4% in 2015 to roughly 12.3% by the end of the forecast period (2022). The cited assertion is based on the expectation of eventual stabilization and renewal of nominal growth in utilization of PCI in the U.S. and Europe coupled with continuation of robust expansion in the usage of percutaneous revascularization techniques in Asia-Pacific (especially India and China, where PCI volumes were growing by 20% and 10% annually over the past half decade, according to local healthcare authorities).
In 2016, the worldwide volume of CABG surgeries leveled at approximately 702.5 thousand procedures, of which roughly 35.2% involved the use of less-invasive OPCAB techniques. During the forecast period, the global number of CABG procedures is projected to experience a nominal 0.1% average annual increase to about 705.9 corresponding surgical interventions in the year 2022. Within the same time frame, the relative share of less-invasive bypass surgeries is expected to register modest gains expanding to approximately 36.7% of the total in 2022.
Coronary Revascularization Procedures, 2015-2022 (Figures in thousands)
In, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022”, Report #C500, we forecast cardiovascular procedure utilization, caseload, technology trends, and device market impacts, for the U.S., Western Europe, Asia/Pacific, and Rest of World.
Wound treatment starts with diagnosis. Acute wounds are often surgically created, or dealt with in accident and emergency (A&E) settings. Diagnosis in the acute scenario usually focuses on cleanliness and tidying of the wound edges to enable securement using sutures or glue products. If major trauma has occurred, hemostats and sealants may be required. In the chronic scenario, diagnosis is a process that occurs at every treatment session. The practitioner will examine size, appearance and odor changes to the wound, and from this process determine the ideal management. In addition, it is likely that the physician will take samples to send for microbial assessment if infection becomes a concern.
Following diagnosis and assessment, treatment will be established based on known efficacy and cost of individual dressings, knowledge of the potential products that may be used, and their availability. This will be determined by reimbursement, local purchasing decisions, and resources.
For chronic wounds, treatment often involves symptoms; many products are designed to remove aesthetically unpleasant aspects of wounds such as exudates, smell, and visibility.
Management of exudates also has a wound-healing benefit. Too much exudate leads to hydrolytic damage and maceration of the tissue and surrounding skin. Too little moisture leads to drying out of the wound and cell death. As a result, many advanced wound management products have been developed to optimize the moist wound healing environment. As a huge variety of wound conditions arise, a large number of dressings has been developed to help manage the full range of circumstances that may be encountered. These include dressings made from foams, polyurethane films, alginates, hydrocolloids, and biomaterials to manage exudates, which may be present in vast quantities (perhaps as much as two liters per square meter per day). Other products are designed to moisten the wound to optimize healing (amorphous hydrogels for example).
Much of the advanced wound management market has evolved to improve exudates management in the home setting, in order to reduce the need for visits by practitioners and the associated cost.
Types and Uses of Select Wound Care Products
Hydrofilm, Release, Tegaderm, Bioclusive
Comes as adhesive, thin transparent polyurethane film, and as a dressing with a low adherent pad attached to the film.
Clean, dry wounds, minimal exudate; also used to cover and secure underlying absorptive dressing, and on hard-to-bandage locations, such as heel.
PermaFoam PolyMem Biatain
Polyurethane foam dressing available in sheets or in cavity filling shapes. Some foam dressing have a semipermeable, waterproof layer as the outer layer of the dressing
Facilitates a moist wound environment for healing. Used to clean granulating wounds which have minimal exudate.
Hydrosorb Gel Sheet, Purilon, Aquasorb, DuoDerm, Intrasite Gel, Granugel
Colloids which consist of polymers that expand in water. Available in gels, sheets, hydrogel-impregnated dressings.
Provides moist wound environment for cell migration, reduces pain, helps to rehydrate eschar. Used on dry, sloughy or necrotic wounds.
CombiDERM, Hydrocoll, Comfeel, DuoDerm CGF Extra Thin, Granuflex, Tegasorb, Nu-Derm
Made of hydroactive or hydrophilic particles attached to a hydrophobic polymer. The hydrophilic particles absorb moisture from the wound, convert it to a gel at the interface with the wound. Conforms to wound surface; waterproof and bacteria proof.
Gel formation at wound interface provides moist wound environment. Dry necrotic wounds, or for wounds with minimal exudate. Also used for granulating wounds.
A natural polysaccharide derived from seaweed; available in a range of sizes, as well as in ribbons and ropes.
Because highly absorbent, used for wounds with copious exudate. Can be used in rope form for packing exudative wound cavities or sinus tracts.
Biatain Ag Atrauman Ag MediHoney
Both silver and honey are used as antimicrobial elements in dressings.
Silver: Requires wound to be moderately exudative to activate the silver, in order to be effective
SNa V.A.C. Ulta PICO Renasys (not in USA) Prospera PRO series Invia Liberty
Computerized vacuum device applies continuous or intermittent negative or sub-atmospheric pressure to the wound surface. NPWT accelerates wound healing, reduces time to wound closure. Comes in both stationary and portable versions.
May be used for traumatic acute wound, open amputations, open abdomen, etc. Seems to increase burn wound perfusion. Also used in management of DFUs. Contraindicated for arterial insufficiency ulcers. Not to be used if necrotic tissue is present in over 30% of the wound.
In some cases, the wound may be covered by a black necrotic tissue or yellow sloughy material. These materials develop from dead cells, nucleic acid materials, and denatured proteins. In order for new tissue to be laid down, this dead material needs to be removed. It may be done using hydrolytic debridement using hydrogels that soften the necrotic tissue, or by the use of enzymes. Surgical debridement is another option, but non-surgical debridement has the advantage that it is usually less painful and can be performed with fewer materials, less expertise, and less mess. It is possible to perform non-surgical debridement in the home setting. Debridement can also be performed to selectively remove dead tissue and thus encourage repair. Enzymatic debriders have been able to command a premium price in the market, and built a sizeable share of the wound management market, particularly during the 1990s when treatment in the home environment increased as a result of reductions in hospital-based treatment. These products are described in the section on cleansers and debriders.
Occasionally healthcare practitioners put maggots to work for wound debridement. Though esthetically unpleasant, maggots are very effective debriding agents because they distinguish rigorously between dead and living tissue. Military surgeons noticed the beneficial effect of maggots on soldiers’ wounds centuries ago, but maggot debridement therapy (MDT) as it is practiced today began in the 1920s and has lately been undergoing something of a revival. The maggots used have been disinfected during the egg stage so that they do not carry bacteria into the wound. The larvae preferentially consume dead tissue, they excrete an antibacterial agent, and they stimulate wound healing.
At the other end of the technological scale are skin substitutes, which have been developed to help in the management of extensive wounds such as burns. Autologous skin grafting is a well-established therapeutic technique; postage-stamp-sized sections of healthy skin are cultured and grown in vitro, then placed over the raw wound surface to serve as a focus for re-epithelialization. However, this process takes time; the wound is highly vulnerable to infection while the skin graft is being grown. A number of companies have developed alternatives in the form of synthetic skin substitutes. These are described further in the next section of the report.
A number of products have also been developed to deal with sloughy and infected wounds. These often incorporate antimicrobial agents. Often, infected wounds have a very unpleasant odor; a range of odor control dressings has arisen to deal with this.
Once wounds begin to heal, the amount of exudate starts to decrease. Some dressing products preserve moisture but are also non-adhesive, so that the dressing does not adhere to the new epithelializing skin. These products are called non-adherent dressings and include a range of tulle dressings, which usually consist of a loose weave of non-adherent fabric designed to allow exudates to pass through the gaps. A subgroup of dressings is designed to keep the skin moist in order to reduce scarring after healing.
For wounds that do not appear to be healing, a number of companies have explored the potential to add growth factors and cells to promote and maintain healing. In addition, companies have attempted to use energy sources to accelerate wound healing, and these are described in the section on physical treatments. The main example of physical treatment is the use of devices which apply negative pressure over the wound and have been shown to dramatically shorten the healing of diabetic ulcers and other chronic wounds.
Often, a dressing will serve more than one purpose. Therefore, it is difficult to generalize and collect only dressings that serve one purpose into a single category. For example, Systagenix’s Actisorb Plus (Systagenix is now owned by Acelity) is a woven, low-adherent odor control antimicrobial dressing designed to optimize moist wound healing through its exudates handling properties.
Stents are implantable devices designed as endoluminal scaffolds to maintain patency following recanalization of occluded or structurally compromised vascular (and non-vascular) circulatory conduits that enable energy supply and metabolic exchange in various organs and tissues of the human body. Palliative stenting has been routinely used for decades in the management of acute and chronic obstructions of gastro-intestinal, pulmonary and urinary tracts secondary to benign or malignant neoplasms or other cite-specific or systemic pathologies. However, a real explosion in utilization of stents was triggered in the early 1990s by the advent of vascular stenting devices, which allowed radically improved clinical outcomes of balloon angioplasty and supported its emergence as the first choice treatment modality for occlusive peripheral and coronary artery disease (PAD and CAD). By the end of 2014, more than three quarters of patients with acute and chronic arterial occlusions warranting intervention were referred for angioplasty-based therapy, which entailed placement of stenting devices in over 80% of commonly performed peripheral revascularization procedures.
To be accepted in clinical practices, stenting implants should satisfy a number of general and application-specific requirements relating to device biocompatibility, functional performance, and end-user and patient friendliness which are summarized in the exhibit below. In very general terms, stenting device biocompatibility refers to minimization of hostile immune responses (and other local and systemic adverse reactions) that are inevitably triggered by a direct contact of any implantable medical device with living tissues and bodily fluids in situ. For understandable reasons, biocompatibility depends primarily on the implant surface material, including such characteristics as chemical inertness and stability, corrosion resistance, etc. The stenting device biocompatibility can also be effected somewhat by the duration of its presence in situ and specifics of the deployment site and occlusion causing pathology.
The stent’s functional performance (or ability to maintain adequate scaffolding support and lumen patency for a desired period of time) represents a complex function of the device design/architecture and the relative static and dynamic strength of its base material. The chosen stenting device’s architecture and structural material predetermine it radial strength, longitudinal flexibility, conformability and foreshortening, as well as relative lesion coverage, fatigue and kinking resistance, circulatory flow obstruction, etc.
Finally, the stent’s end-user and patient friendliness are predicated both by the design concept of the delivery system and stenting device and refers to procedural convenience, predictability, safety, morbidity, availability of bail-out options, etc. The commonly acknowledged stenting system characteristics relating to the end-user/patient friendliness include low profile, flexibility, traceability, high radiopacity, compatibility with established transcatheter tools and techniques, ease of use and short learning curve, simplicity of retrieval in case of procedural failure, possibility of emergent /elective conversion to surgery, etc.
Selected Biomedical, Clinical and Technical Requirements for Stenting Implants
Coronary revascularization, whether by bypass graft or percutaneous coronary intervention, drives an enormous amount of medtech business. Angioplasty catheters, guidewires, and the plethora of devices in cardiothoracic surgery represent many millions in sales annually. Manufacturers pursuing growth in these areas will see big, but slowing growth rates in the U.S., while markets in Asia/Pacific reflect the growing demand for cardio technologies. Already, these markets are surpassing western markets:
While coronary applications have a long history, venous interventions have less, and procedure data shows that patient populations have not been fully tapped in any geographic region. Already, Asia/Pacific markets would appear to be on course to eclipse western markets, but not until after 2022, and will eclipse Western Europe markets before challenging the U.S.
With few exceptions, cardiovascular technologies no longer command big premiums (like many other medtech sectors) and mature Western markets for cardio devices have already captured most of the readily available patient caseloads. The lines between different markets (device, drugs, materials) are blurring, while surgical specialists seek to slow the caseload migration to interventionalists. The epicenter of growth in utilization of advanced cardiovascular technologies and techniques is gradually shifting to emerging Asia-Pacific markets away from the increasingly stagnant U.S. and Western European marketplace. The latter reflects the sheer size of underserved patient caseloads, availability of funding, and increasing reliance on economical domestically reproduced sophisticated endovascular devices.
“In order to be successful, manufacturers, investors, healthcare providers, advisors, and others in cardiac surgery and endovascular fields need to understand the real dynamics and asymmetrical development pattern of different cardiovascular device markets in different geographies,” says Patrick Driscoll of MedMarket Diligence. “At the root of understanding the market is accurately and realistically gauging the current and future demand for, and likely usage of, specific medical and surgical technologies and procedures.”
MedMarket Diligence has published a comprehensive resource available to manufacturers, investors, and others with interest in cardiovascular technologies. “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” is a worldwide competitive analysis and forecast of existing and emerging cardiovascular technologies and procedures coupled with identification and assessment of the most promising and sizable device markets.
The report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting the myocardium and vascular system. The latter include ischemic heart disease (and its life threatening manifestations like AMI, cardiogenic shock, etc.); heart failure; structural heart disorders (valvular abnormalities and congenital heart defects); peripheral artery disease (and limb and life threatening critical limb ischemia); aortic disorders (AAA, TAA and aortic dissections); acute and chronic venous conditions (such as deep venous thrombosis, pulmonary embolism and chronic venous insufficiency); neurovascular pathologies associated with high risk of hemorrhagic and ischemic stroke (such as cerebral aneurysms and AVMs, and high-grade carotid/intracranial stenosis); and cardiac rhythm disorders (requiring correction with implantable pulse generators/IPG or arrhythmia ablation).
The report offers epidemiology and mortality data for the major cardiovascular conditions along with current assessment and projected procedural dynamics (2015 to 2022) for primary market geographies (e.g., United States, Largest Western European Countries, and Major Asian States) as well as the rest of the world.
Methodology. The MedMarket Diligence procedural assessments and forecasts are based on the systematic analysis of a multiplicity of sources including (but not limited to):
Latest and historic company SEC filings, corporate presentations, and interviews with product management and marketing staffers;
Data released by authoritative international institutions (such as OECD and WHO), and national healthcare authorities;
Statistical updates and clinical practice guidelines from professional medical associations (like AHA, ACC, European Society of Cardiology, Chinese, Indian, and Japanese Societies of Cardiology, etc.);
Specialty presentations at major professional conferences (e.g., TCT, AHA Scientific Sessions, EuroPCR, etc.);
Publications in major medical journals (JAMA, NEJM, British Medical Journal, Lancet, etc.) and specialty magazines (CathLab Digest, Endovascular Today, EPLab Digest, etc.);
Findings from relevant clinical trials;
Feedback from leading clinicians (end-users) in the field on device/procedure utilization trends and preferences; and
Policy papers by major medical insurance carriers on uses of particular surgical and interventional tools and techniques, their medical necessity and reimbursement.
Surgical and Interventional Procedures Covered:
Coronary artery bypass graft (CABG) surgery;
Coronary angioplasty and stenting;
Lower extremity arterial bypass surgery;
Percutaneous transluminal angioplasty (PTA) with and without bare metal and drug-eluting stenting;
Peripheral drug-coated balloon angioplasty;
Surgical and endovascular aortic aneurysm repair;
Vena cava filter placement;
Mechanical venous thrombectomy;
Venous angioplasty and stenting;
Carotid artery stenting;
Cerebral aneurysm and AVM surgical clipping;
Cerebral aneurysm and AVM coiling & flow diversion;
Left Atrial Appendage Closure;
Heart valve repair and replacement surgery;
Transcatheter valve repair and replacement;
Congenital heart defect repair;
Percutaneous and surgical placement of temporary and permanent mechanical cardiac support devices;
The global market for cardiovascular devices is in the billions. Its size and association with life-saving clinical utility ensures that investors will support a surprisingly strong range of innovations in an otherwise very well-established medtech market. There is stable growth in many cardio technologies that have attained “gold standard”; aggressive growth in China, India, and Japan; and select new cardio technologies expected to rapidly seize caseload.
Report #C500, excerpted below, provides forecasts and analysis of cardiovascular surgical and interventional procedures to illustrate the volume and growth by clinical area, caseload trend, practice trend, technology introduction or regional dynamic impact.
During the forecast period 2016 to 2022, the total worldwide volume of cardiovascular surgical and interventional procedures, tracked by MedMarket Diligence, is forecast to expand on average by 3.7% per annum to over 18.73 million corresponding surgeries and transcatheter interventions in the year 2022. The largest absolute gains can be expected in peripheral arterial interventions (thanks to explosive expansion in utilization of drug-coated balloons in all market geographies), followed by coronary revascularization (supported by continued strong growth in Chinese and Indian PCI utilization) and endovascular venous interventions (driven by grossly underserved patient caseloads within the same Chinese and Indian market geography).
The latter (venous) indications are also expected to register the fastest (5.1%) relative procedural growth, followed by peripheral revascularization (with 4.0% average annual advances) and aortic aneurysm repair (projected to show a 3.6% average annual expansion).
Geographically, Asian-Pacific (APAC) market geography accounts for slightly larger share of the global CVD procedure volume than the U.S. (29.5% vs 29,3% of the total), followed by the largest Western European states (with 23.9%) and ROW geographies (with 17.3%). Because of the faster growth in all covered categories of CVD procedures, the share of APAC can be expected to increase to 33.5% of the total by the year 2022, mostly at the expense of the U.S. and Western Europe.
However, in relative per capita terms, covered APAC territories (e.g., China and India) are continuing to lag far behind developed Western states in utilization rates of therapeutic CVD interventions with roughly 1.57 procedures per million of population performed in 2015 for APAC region versus about 13.4 and 12.3 CVD interventions done per million of population in the U.S. and largest Western European countries.
The rationale for the development of drug-coated angioplasty balloons (DCBs) derives mainly from the limitations of drug-eluting stents (DES). Nonstent-based localized drug delivery using a DCB maintains the antiproliferative properties of a DES, but without the immunogenic and hemodynamic drawbacks of a permanently implanted endovascular device. Moreover, DCBs may be used in subsets of lesions where DES cannot be delivered or where DES do not perform well. Examples include torturous vessels, small vessels or long diffuse calcified lesions, which can result in stent fracture; when scaffolding obstructs major side branches; or in bifurcated lesions.
Additional potential advantages of DCBs include:
homogenous drug transfer to the entire vessel wall;
rapid release of high concentrations of drug sustained in vessel wall no longer than a week, with little impact on long-term healing;
absence of polymer, which reduces the risk of chronic inflammation and late thrombosis;
absence of a stent, preserving the artery’s original anatomy, very important in bifurcations or small vessels to diminish abnormal flow patterns; and
avoided need for lengthy antiplatelet therapy.
Currently, paclitaxel is primarily used by DCB manufacturers. Its high lipophilic property allows for passive absorption through the cell membrane and sustained effect within the treated vessel wall.
Below we illustrate the rise of drug-coated balloons for peripheral angioplasty procedures in lower extremities.
The usage of peripheral DCB in clinical practices can be expected to experience explosive growth in superficial femoral artery and femoro-popliteal below-the-knee indications to over half a million procedures annually by the year 2022. Anticipated rapid adoption of peripheral DCB technologies in the U.S. and major Asia-Pacific States (especially in China and India accounting for 95% of the covered region’s population) should work as a primary locomotive of growth of projected global procedural expansion.
A great deal of market development has yet to take place in the field of wound closure, especially for advanced sealants, glues, and hemostats — let’s just for convenience call them “liquid closure” (as opposed to sutures/staples/clips). It is currently in an evolving, growing, consolidating, tweaking state of change, with currently more upside coming out of Asia than from innovations in sealing, adhesion, or hemostasis.
Market players dominant in one geography are absent in others. The rate of market growth arising from innovation lags growth from penetrating emerging markets, where manufacturers have rushed to pick the easy fruit.
Challenges remain in order for “liquid closure” to more deeply penetrate a caseload otherwise served by docs using strong, easy-to-use sutures, clips, and staples. Sealants are terrific in adjunctive use by “caulking” suture lines to ensure nothing leaks between, no matter how strongly the clips, etc. are holding. But the strength of sealing and adhesion are not sufficient for most products to do the job alone. A “liquid closure” must be many things with high standards that have largely yet to be met.
Hemostats, though, given their simple function to keep the life from draining out of people, have succeeded handsomely in saving lives.
For the near term, the growth in liquid closure sales is evident most strongly in Asia, with income and other drivers there giving life to an otherwise staid market, for the time being…
The initial use of cerebral thrombectomy systems has been a disappointment. It is generally assumed that the situation with end-user adoption is likely to improve dramatically in two-three years from now, when results of the ongoing major U.S. and international trials with novel cerebral thrombectomy devices become available. Growth will exceed 11% annually through 2022.
#4 Below-the-knee drug-coated balloon angioplasty for superficial femoral artery.
There is now a broad-based consensus among leading interventional radiologists that peripheral angioplasty using DCBs should be seen as a first-line revascularization option for both primary treatment and revision of advanced arterial occlusions in the SFA vascular territory. This will lead to better than 14% annual growth in these procedures through 2022.
#3 Transcatheter heart valve replacement.
The use of transcatheter techniques in heart valve replacement and repair is projected to grow at over 14%, to be supported by the anticipated regulatory approval of TAVR procedures for intermediate risk patients in late 2016, and, plausibly, for standard surgical risk caseloads by 2019.
#2 Left atrial appendage endovascular closure in AFib.
The global volume of endovascular LAA closure procedures is projected to experience a robust double-digit growth expanding an average of over 14% annually, nearly doubling to an estimated 52 thousand corresponding interventions in the year 2022. Anticipated strong growth in the endovascular LAA closure utilization will be driven by increasing penetration of the Asian-Pacific (primarily Chinese and Indian) market geography with an extra boost from the recent U.S. launch of transcatheter LAA closure systems. Advances in the mature European market and emerging ROW marketplace are likely to stay below projected average growth rates.
#1 Lower extremity angioplasty and DES procedures.
Lower extremity angioplasty and drug-eluting stenting is forecast to increase almost three-fold from 2016 to 2022.
From 2015 to 2022, the cumulative global volume of PTA procedures is projected to expand an average of 4.2% per annum to year 2022. The cited expansion will be driven largely by a strong annual procedural growth in the APAC region (primarily in China and India undergoing aggressive transition to modern interventional radiology practices), which is forecast to account for about over a third of PTAs performed worldwide in 2022. The U.S. and Western European geographies can be expected to register only a moderate PTA procedural growth to be supported mostly by increasing penetration of the SFA patient caseloads with DES-based interventions, but the worldwide utilization of stented PTAs (especially these employing DES devices) is forecast to grow at significantly faster (4.2% and 19.1%) average annual rates to over 986,000 and 203,000 corresponding procedures in the year 2022.