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.

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

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.

List of high growth medtech products

Below is a table with a list of the market segments demonstrating greater than 10% compound annual growth rate for the associated region through 2022, drawn from our reports on tissue engineering & cell therapy, wound management, ablation technologies, stroke, peripheral stents, and sealants/glues/hemostats. Products with over 10% CAGR in sales are shown in descending order of CAGR.

RankProductTopicRegion
1General, gastrointestinal, ob/gyn, othertissue/cellWW
2Ophthalmologytissue/cellWW
3Organ Replacement/ Repairtissue/cellWW
4Urologicaltissue/cellWW
5Neurologicaltissue/cellWW
6Autoimmune Diseasestissue/cellWW
7CV/ Vasculartissue/cellWW
8Bioengineered skin and skin substituteswoundRest of A/P
9Peripheral drug-eluting stents (A/P)peripheral interventionalA/P
10Peripheral drug eluting stentsperipheral interventionalRoW
11Peripheral drug-eluting stents (US)peripheral interventionalUS
12Negative pressure wound therapywoundGermany
13Hydrocolloid dressingswoundRest of A/P
14Cancertissue/cellWW
15Foam dressingswoundRest of A/P
16Growth factorswoundRest of A/P
17Alginate dressingswoundRest of A/P
18Dentaltissue/cellWW
19Bioengineered skin and skin substituteswoundJapan
20Hemostatssealants, glues, hemostatsA/P
21Skin/ Integumentarytissue/cellWW
22Bioengineered skin and skin substitutessealants, glues, hemostatsUS
23Bioengineered skin and skin substitutessealants, glues, hemostatsWW
24Film dressingswoundRest of A/P
25Surgical sealantssealants, glues, hemostatsA/P
26Hydrogel dressingswoundRest of A/P
27TAA Stent graftsperipheral interventionalA/P
28Negative pressure wound therapywoundRoW
29Biological gluessealants, glues, hemostatsA/P
30FoamwoundRoW
31HydrocolloidwoundGermany
32AAA Stent graftsperipheral interventionalA/P
33Cerebral thrombectomy systemsstrokeA/P
34High-strength medical gluessealants, glues, hemostatsA/P
35Carotid artery stenting systemsstrokeA/P
36Cardiac RF ablation productsablationA/P
37Alginate dressingswoundGermany
38Peripheral venous stentsperipheral interventionalA/P
39Cerebral thrombectomy systemsstrokeUS
40Left atrial appendage closure systemsstrokeA/P
41Cyanoacrylate gluessealants, glues, hemostatsA/P
42Foam dressingswoundRest of EU
43Foam dressingswoundKorea
44Cryoablation cardiac & vascular productsablationA/P
45Bioengineered skin and skin substituteswoundGermany
46Thrombin, collagen & gelatin-based sealantssealants, glues, hemostatsA/P
47Cardiac RF ablation productsablationRoW
48Bioengineered skin and skin substituteswoundRoW
49Microwave oncologic ablation productsablationA/P

Note source links: Tissue/Cell, Wound, Sealants/Glues/Hemostats, Peripheral Stents, Stroke, Ablation.

Source: MedMarket Diligence Reports

Cardiovascular Surgical Procedures, Technologies Trended Globally to 2022

cardiovascular procedures

Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022. See Report #C500.

Publishing July 2016

This report covers surgical and interventional therapeutic procedures commonly used in the management of acute and chronic conditions affecting 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 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.

See the complete table of contents at Report C500.

 

 

Fibrin, Thrombin, Collagen and Gelatin-Based Sealants, 2016 & 2022

fibrin2016

Source: MedMarket Diligence, LLC; Report #S290 (July 2016).

fibrin2022

Source: MedMarket Diligence, LLC; Report #S290 (July 2016).

collagen2016

Source: MedMarket Diligence, LLC; Report #S290 (July 2016).

collagen2022

Source: MedMarket Diligence, LLC; Report #S290 (July 2016).

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.