Cardiovascular procedure volume growth (interventional and surgical)

Cardiovascular surgical and interventional procedures are performed to treat conditions causing inadequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. These conditions include the obstruction or deformation of arterial and venous pathways, distortion in the electrical conducting and pacing activity of the heart, and impaired pumping function of the heart muscle, or some combination of circulatory, cardiac rhythm, and myocardial disorders. Specifically, these procedures are:

  • 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;
  • Peripheral atherectomy;
  • Surgical and endovascular aortic aneurysm repair;
  • Vena cava filter placement
  • Endovenous ablation;
  • Mechanical venous thrombectomy;
  • Venous angioplasty and stenting;
  • Carotid endarterectomy;
  • Carotid artery stenting;
  • Cerebral thrombectomy;
  • 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;
  • Pacemaker implantation;
  • Implantable cardioverter defibrillator placement;
  • Cardiac resynchronization therapy device placement;
  • Standard SVT & VT ablation; and
  • Transcatheter AFib ablation

For 2016 to 2022, the total worldwide volume of these cardiovascular procedures is forecast to expand on average by 3.7% per year 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).

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).

Source: MedMarket Diligence, LLC; “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” (Report #C500).

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.

Source: MedMarket Diligence, LLC; “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022,” (Report #C500).


Global Cardiovascular Procedures report #C500 details the current and projected surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting myocardium and vascular system.

High strength medical and surgical glues, growth to 2022

High strength medical and surgical glues currently command a $1.2 billion market that will grow to $1.7 billion by 2022, representing a 6.4% compound annual growth rate. More importantly, however, is that during this time frame the market will undergo steady shifts, including the regional representation, with growth slowing in western markets relative to Asia-Pacific and the rest of the world.

Below is illustrated the size versus growth of high strength glues in the U.S., Western Europe, Asia-Pacific and Rest of World.

Source: MedMarket Diligence, LLC; Report #S290. Order online.

The resulting differential growth over this period will result in a shift in the regional market balance, as shown below.

Source: MedMarket Diligence, LLC; Report #S290. Order online.

Source: MedMarket Diligence, LLC; Report #S290. Order online.

Market fragmentation and growth, decline in wound management

The market for wound management products — as varied as negative pressure wound therapy, skin grafts, hydrogel dressings, and growth factors — is a sort of free-for-all of offerings designed to accelerate healing, reduce treatment costs, yield better outcomes, or all of these and more. With so many sectors, and with well-established ones tending toward commodity, there can be many competitors, with few having significant market shares. Yet in several areas, quite remarkable growth is still available.  Excluding traditional bandage and dressings, three companies — S&N, Acelity and Mölnlycke — control over half the worldwide market.

Global Advanced Wound Market Market Shares

Source: MedMarket Diligence, LLC; Report #S251. Order online.

Growth is coming in the advanced areas of bioengineered skin, the ever-needed antimicrobials, and the great demand for foam dressings.


Source: MedMarket Diligence, LLC; Report #S251. Order online.

 

Viewed another way, with size and growth mapped relative to each other…

 

Source: MedMarket Diligence, LLC; Report #S251. Order online.

The U.S. remains the biggest consumer of wound management products, and this is not expected to materially change. Europe is seeing relative decline, however, as Asia Pacific demand ramps up:

Source: MedMarket Diligence, LLC; Report #S251. Order online.


The MedMarket Diligence report #S251, “Worldwide Wound Management, Forecast to 2024: Established and Emerging Products, Technologies and Markets in the Americas, Europe, Asia/Pacific and Rest of World,” is detailed at link and is available for purchase and download online

Medical and Surgical Sealants, Glues, and Hemostats, to 2022

There are several different classes of surgical sealants, glues and hemostatic products used to prevent or stop bleeding, or to close a wound or reinforce a suture line. These include fibrin sealants, surgical sealants, mechanical hemostats, active hemostats, flowable hemostats, and glues. Both sealants and medical glues are increasingly used either as an adjunct to sutures or to replace sutures.

Medical Sealants

Fibrin sealants are made of a combination of thrombin and fibrinogen. These sealants may be sprayed on the bleeding surface, or applied using a patch. Surgical sealants might be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates.

Sealants are most often used to stop bleeding over a large area. If the surgeon wishes to fasten down a flap without using sutures, or in addition to using sutures, then the product used is usually a medical glue.

Source: MedMarket Diligence, LLC; Report #S290.

Hemostatic Products

The surgeon and the perioperative nurse have a variety of hemostats from which to choose, as they are not all alike in their applications and efficacy. Selection of the most appropriate hemostat requires training and experience, and can affect the clinical outcome, as well as decrease treatment costs. Some of the factors that enter into the decision-making process include the size of the wound, the amount of hemorrhaging, potential adverse effects, whether the procedure is MIS or open surgery, and others.

Active hemostats contain thrombin products which may be derived from several sources, such as bovine pooled plasma purification, human pooled plasma purification, or through human recombinant manufacturing processes. Flowable-type hemostats are made of a granular bovine or porcine gelatin that is combined with saline or reconstituted thrombin, forming a flowable putty that may be applied to the bleeding area.
Mechanical hemostats, such as absorbable gelatin sponge, collagen, cellulose, or polysaccharide-based hemostats applied as sponges, fleeces, bandages, or microspheres, are not included in this analysis.

Source: MedMarket Diligence, LLC; Report #S290.

Medical Glues

Sealants and glues are terms which are often used interchangeably, which can be confusing. In this report, a medical glue is defined as a product used to bond two surfaces together securely. Surgeons are increasingly reaching for medical glues to either help secure a suture line, or to replace sutures entirely in the repair of soft tissues. Medical glues are also utilized in repairing bone fractures, especially for highly comminuted fractures that often involve many small fragments. This helps to spread out the force-bearing surface, rather than focusing weight-bearing on spots where a pin has been inserted.

Thus, the surgeon has a fairly wide array of products from which to choose. The choice of which surgical hemostat or sealant to use depends on several factors, including the procedure being conducted, the type of bleeding, severity of the hemorrhage, the surgeon’s experience with the products, the surgeon’s preference, the price of the product and availability at the time of surgery. For example, a product which has a long shelf life and does not require refrigeration or other special storage, and which requires no special preparation, usually holds advantages over a product which must be mixed before use, or held in a refrigerator during storage, then allowed to warm up to room temperature before use.

Source: MedMarket Diligence, LLC; Report #S290.


From “Worldwide Market for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” See details at link. Order online.

Hemostat Sales to 2022

Owing to their ease of use, ease of handling, and general clinical utility, hemostat sales will almost double worldwide between 2016 and 2022:

Source: MedMarket Diligence, LLC; Report #S290. Order online.

Hemostat sales are exceptionally strong in the well developed economies (Japan, Australia, Korea) of Asia, and will continue to expand there with the rapidly growing contribution of China’s hemostat sales.

Source: MedMarket Diligence, LLC; Report #S290. Order online.

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Regional Markets for Surgical Sealants, 2015 and 2022

The fastest growth in the sales of surgical sealants over the next decade will be in the Asia-Pacific region, driven primarily by very strong healthcare market growth in China, and reaching a CAGR (2016-2022) of at least 13.97%. The growth rate in China would be even higher, but will be dampened for the time being by the lack of surgeons trained in the proper use of these products, as well as the limitations of reaching a dispersed patient population. Nonetheless, the A/P share of the global sealants market will double in the next seven years!

Below illustrates the geographic distribution of surgical sealants (fibrin and others) in 2015.

Regional Markets for Sealants, Fibrin and Other Sealant Products,
2015 & 2022, USD Millions

2015screen-shot-2016-11-11-at-8-52-44-am

2022

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Source: MedMarket Diligence, LLC; Report #S290.


Report #S290 may be purchased online for PDF download or print delivery; in single, site, or global licenses.

Cardiovascular Surgical and Interventional Procedures Worldwide, 2015-2022

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).

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CABG: Coronary artery bypass graft; PCI: Percutaneous coronary intervention; AAA: Abdominal aortic aneurysm; TAA: Thoracic abdominal aneurysm; CVI: Chronic venous insufficiency; DVT: Deep vein thrombosis; PE: Pulmonary embolectomy.

Source: MedMarket Diligence, LLC; Report #C500, “Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.” (To request report excerpts, click here.)

The Regimens for Assessing and Treating Wound Types

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

    
Dressing categoryProduct examplesDescriptionPotential applications
FilmHydrofilm, Release, Tegaderm, BioclusiveComes 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.
FoamPermaFoam
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 dressingFacilitates a moist wound environment for healing. Used to clean granulating wounds which have minimal exudate.
HydrogelHydrosorb Gel Sheet, Purilon, Aquasorb, DuoDerm, Intrasite Gel, GranugelColloids 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.
HydrocolloidCombiDERM, Hydrocoll, Comfeel, DuoDerm CGF Extra Thin, Granuflex, Tegasorb, Nu-DermMade 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.
AlginateAlgiSite, Sorbalgon Curasorb, Kaltogel, Kaltostat, SeaSorb, TegagelA 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.
AntimicrobialBiatain 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
NPWDSNa
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.
Bioengineered Skin and Skin SubstitutesAlloDerm, AlloMax, FlexHD, DermACELL, DermaMatrix, DermaPure, Graftjacket Regenerative Tissue Matrix, PriMatrix, SurgiMend PRS, Strattice Reconstructive Tissue Matrix, Permacol, EpiFix, OASIS Wound Matrix, Apligraf, Dermagraft, Integra Dermal Regeneration Template, TransCyteBio-engineered skin and soft tissue substitutes may be derived from human tissue (autologous or allogeneic), xenographic, synthetic materials, or a composite of these materials.Burns, trauma wounds, DFUs, VLUs, pressure ulcers, postsurgical breast reconstruction, bullous diseases

Source: MedMarket Diligence, LLC; Report #S251.

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.


From, Worldwide Wound Management, Forecast to 2024; MedMarket Diligence, LLC. 

Requirements for acceptance of new peripheral stents in clinical practice

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

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Source: MedMarket Diligence, LLC; Report #V201.

Coronary and venous interventions show inevitable Asia/Pacific dominance

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:

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Source: Report #C500.

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.

screen-shot-2016-10-03-at-2-20-38-pm

Source: Report #C500.