Interventional and Surgical Cardiovascular Procedure Volumes

Cardiovascular diseases (CVDs) are a variety of acute and chronic medical conditions associated with an inability of the cardiovascular system to sustain an adequate blood flow and supply of oxygen and nutrients to organs and tissues of the body. The CVD conditions may be manifested by 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.

These diseases are treated via the following surgical and interventional procedures:

  • 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

In 2016, the cumulative worldwide volume of these procedures is projected to approach 15.05 million surgical and transcatheter interventions. This will include:

  • 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).

Below is illustrated the overall global growth for each of the major categories of procedures through 2022.

Source: MedMarket Diligence, LLC; Report #C500.  (Full report available online.)

There is considerable variation in the growth of cardiovascular procedures globally, but most growth is coming out of Asia/Pacific. For example, within the area of venous interventions, the growth in the use of endovenous ablation for chronic venous insufficiency is markedly higher in Asia/Pacific than in other regions, though the U.S. will remain the largest volume of these procedures.

Source: MedMarket Diligence, LLC; Report #C500.  (Full report available online.)


“Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022” (Report #C500), published August 2016. See description, table of contents, list of exhibits at link. Available for purchase and download from link.

Peripheral Stenting Worldwide: Arterial, Venous, BMS, DES, AAA, TAA

First introduced about two decades ago as a bailout technique for suboptimal or failed iliac angioplasty, peripheral vascular stenting gradually emerged as a valuable and versatile tool for a variety of primary and adjuvant applications outside the domain of coronary and cerebral vasculature.  Today, peripheral vascular stenting techniques are commonly employed in the management of the most prevalent occlusive circulatory disorders and other pathologies affecting the abdominal and thoracic aortic tree and lower extremity arterial bed. Stents are also increasingly used in the management of the debilitating conditions like venous outflow obstruction associated with deep venous thrombosis and chronic venous insufficiency.

Notwithstanding a relative maturity of the core technology platforms and somewhat problematic opportunities for conversion to value-adding peripheral drug-eluting systems, peripheral vascular stenting appears to have a significant room for qualitative and quantitative growth both in established and emerging peripheral indications.

A panoply of stenting systems are available for the management of occlusive disorders and other pathologies affecting peripheral arterial and venous vasculature. Systems include lower extremity bare metal and drug-eluting stents for treatment of symptomatic PAD and critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in CVI.

In 2015, these peripheral stenting systems were employed in approximately 1.565 million revascularization procedures worldwide, of which the lower extremity arterial stenting accounted for almost 1.252 million interventions (or 80.9%), followed by AAA and TAA endovascular repairs with 162.4 thousand interventions (or 10.5%) and peripheral venous stenting used in an estimated 132.6 thousand patients (or 8.6% of the total).

The U.S. clinical practices performed almost 528 thousand covered peripheral arterial and venous procedures (or 34.1% of the worldwide total), followed by the largest Western European states with over 511 thousand interventions (or 33.1%), major Asian-Pacific states with close to 377 thousand interventions (or 24.4%), and the rest-of-the-world with about 131 thousand peripheral stent-based interventions (or 8.4%).

Below is illustrated the global market for peripheral stenting by region in 2016 and by segment from 2014 to 2020.

Source: MedMarket Diligence, LLC; Report #V201. Available online.

 

Source: MedMarket Diligence, LLC; Report #V201. Available 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.

Upside from innovation, emerging markets for sealants, glues, hemostats

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…

sealants glues hemostat overlap
MedMarket Diligence, LLC; Report #S290.

Growth in Advance Wound Care Product Revenues, 2014 to 2024

Even excluding the three traditional wound care dressing segments, the advanced wound care market is enormous — over the next ten years, it will grow at a compound annual growth rate of at least 7.7%, and is forecast to reach nearly $16 billion by 2024. This market is being driven by several inter-related factors: the increasing percentage of the aged (65years old and over) in country populations, the fact that people are living longer, obesity, the virtually epidemic rise of Type 2 diabetes, government policies intended to curb healthcare spending, and an increasingly sedentary population. The latter trend is seen especially in developed countries, but is also on the rise in less-developed countries as their economic standing improves and the middle class grows in numbers.

Certain product segments are forecast to have stronger growth than others. Sales of bioengineered skin & skin substitutes for wound care will increase at a CAGR of at least 15%, while sales of foam and hydrocolloid dressings will be growing at high single-digit rates, respectively.

Advance Wound Care Product Revenues, 2014 to 2024

Wound 2014 and 2024

Source: MedMarket Diligence, LLC; Report #S251.

Growth in wound management from trends in prevalence, technology

Worldwide, an enormous number of wounds are driving a $15 billion market that will soon pass $20 billion. What is driving wound sales is the continued growth and prevalence of different wound types targeted by medical technologies ranging from bandages to bioengineered skin, physical systems like negative pressure wound therapy, biological growth factors, and others.

Most attention in wound management is focused on improving conventional wound healing in difficult clinical situations, especially for chronic wounds, in the expansion of wound management technologies to global markets, and in the application of advanced technologies to improve healing of acute wounds, especially surgical wounds.

Global Prevalence of Wound Types, 2015

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Source: MedMarket Diligence LLC; Report #S251. Request excerpts from this report.

Total Wound Care Market as Percent of Entire Market, 2024

Screen Shot 2016-03-02 at 12.44.46 PM

Source: MedMarket Diligence LLC; Report #S251. Request excerpts from this report.


 

Peripheral Vascular Stenting to 2020

First introduced about two decades ago as a bailout technique for suboptimal or failed iliac angioplasty, peripheral vascular stenting gradually emerged as a valuable and versatile tool for a variety of primary and adjuvant applications within non-coronary vasculature.

Today, peripheral vascular stenting techniques are commonly employed in the management of the most prevalent occlusive circulatory disorders and other pathologies affecting abdominal and thoracic aortic tree and lower extremity arterial bed. Stents are also increasingly used in the management of the debilitating conditions like venous outflow obstruction associated with deep venous thrombosis and chronic venous insufficiency.

Peripheral vascular systems include lower extremity bare metal and drug-eluting stents for treatment of symptomatic PAD and critical limb ischemia resulting from iliac, femoropopliteal and infrapopliteal occlusive disease; stent-grafting devices used in endovascular repair of abdominal and thoracic aortic aneurysms; as well as a subset of indication-specific and multipurpose peripheral stents used in recanalization of iliofemoral and iliocaval occlusions resulting in CVI.

In 2015, these peripheral stenting systems were employed in ovet 1.5 million revascularization procedures worldwide, of which lower extremity arterial stenting accounted for 81% of such interventions, followed by abdominal aortic aneurysm and thoracic aortic aneurym endovascular repairs.

Clinicians in the U.S. performed 34.1% of worldwide covered peripheral arterial and venous procedures,  followed by the major Western European countries (33.1%), major Asian-Pacific states (24.4%), and the rest-of-the-world with 8.4% of peripheral stent-based interventions.

During the forecast period, the global volume of peripheral arterial and venous stenting procedures is projected to grow an average of 5.5% and 6.2% per annum, generating over $4,620 million in cumulative product revenues in the year 2020.

The largest relative and absolute dollar gains in all covered product segments can be expected in Asian-Pacific market geography based on rapid transition to modern interventional radiology practices and availability of funding in China. Similar, but somewhat slower growth trends might be observes in the ROW zone, albeit from a much lower base.

Highly mature U.S. and Western European markets are likely to register relatively modest advances both in corresponding procedure volumes and device sales.

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Source: MedMarket Diligence, LLC; Report #V201, “Global Market Opportunities in Peripheral Arterial and Vascular Stents, Forecast to 2020” publishing February 2016).

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Source: MedMarket Diligence, LLC; Report #V201

 

Forecasts for neurointerventions in acute stroke

Over the past two decades, one could witness the advent and significant expansion of the neurointerventional armamentarium targeting management of acute stroke. In mid-1990s, endovascular coiling embolization tools and techniques for treatment of cerebral aneurysms and AVMs (arterio-venous malformations) were introduced as a less invasive alternative to craniotomy-based surgery in primary prevention of hemorrhagic stroke. Several years later, these techniques were supplemented with coil-containing stents, which enabled treatment of large, giant, and wide-neck aneurysms. The latter was followed by the launch of stent-based flow diversion systems, which allowed clinicians to hemoisolate such aneurysms without tedious and risky coil packing of the rupture-prone aneurysmal sac.

In primary ischemic stroke prevention, development of embolically-protected carotid stenting and left atrial appendage closure techniques provided clinicians with an option of using non-inferior transcatheter tools instead of customary surgical interventions.

Finally, a recent launch of the novel stent-based cerebral thrombectomy systems manifested a qualitative breakthrough in emergent treatment of acute cerebral ischemia, where marginally effective and severely caseloads restrictive intravenous tPA therapy represented the only available therapeutic option.

Presently, endovascular techniques are increasingly seen and used by practicing clinicians as preferred therapeutic modalities in prophylaxis and treatment of acute stroke and are likely to expand their role in the years to come.

Based on the industry reporting and other estimates, in 2014, approximately 227.3 thousand cerebral endovascular therapeutic procedures were performed worldwide. Prophylaxis of ischemic stroke via carotid artery stenting and left atrial appendage (LAA) closure with contributed 91.2 thousand and 11.9 thousand interventions (or 40.1% and 5.2%, accordingly), followed by transcatheter embolization of intracranial aneurysm and AVM for hemorrhagic stroke prevention with 90.5 thousand interventions (or 39.8%), and cerebral thrombectomy-based emergent treatment of acute cerebral ischemia with 33.7 procedures (or 14.8% of the total).

Geographically, Western Europe and the U.S. accounted for the largest shares of corresponding cerebrovascular interventions in 2014, with 35.7% and 35.0%, accordingly, followed by major APAC states with 19% and rest-of-the-world with the remaining 10.3% of the total procedures performed.

Source: MedMarket Diligence, LLC; Report #C310.

 

Spine Surgery is Led By the U.S. and Thoracolumbar Fusion

From, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021”, Report #M540.

Spine surgery remains a uniquely American pastime, based at least on sales of technologies including spinal fusion, minimally invasive spine surgical technologies, and orthobiologics used for spine.

The patient demand and associated utilization rates, prices, reimbursement and other drivers make the U.S. an even bigger than it is in most medtech markets. And globally, as well as in the U.S., thoracolumbar fusion drives the most sales.

 


 

From, “Global Market For Medical Device Technologies in Spine Surgery, 2014-2021”, Report #M540.

Top Growth Wound Care Product Sales By Country

Whether sales growth arises by a preferred adoption of one technology over another or by better than average economic conditions — or both, sales of wound management products are driven by technology adoption rates that vary by country, clinical practice patterns, reimbursement and other variables.

We assessed current and forecast sales for the following products:

  • Trad’l Adhesive Dressings
  • Trad’l Gauze
  • Trad’l Non-Adherent
  • Film
  • Foam
  • Hydrogel
  • lHydrocolloid
  • Alginate
  • Antimicrobial
  • Negative Pressure Wound Therapy
  • Bioengineered Skin & Skin Substitutes
  • Growth Factors

For all product segments but the traditional adhesive, gauze, and non-adherent wound care products (which were assessed only at the global level), we assessed growth in each of the following countries/regions: Americas (USA, Rest of North America, Latin America), Europe (United Kingdom, Germany, Italy, France, Spain, Rest of Europe), Asia/Pacific (Japan, Korea, Rest of Asia/Pacific), and Rest of World.

 

From our examination (report #S251) of the global market for wound management products, below are the top product-country cohorts in terms of projected compounded sales growth from 2015 to 2024.