Cerebral thrombectomy procedures worldwide

In 2014, approximately 33.7 thousand cerebral thrombectomy procedures were performed worldwide, of which United States and largest European states accounted for roughly 46% and 37%, largest Asian states contributed 10.4% and the rest of the world added remaining 6.5%.

The 2014 global cerebral thrombectomy system sales were estimated at approximately $166 million, of which the United States accounted for about $79.1 million (or ~47.7%), followed by the largest Western European states with $59.4 million (or 35.8%), major Asian states with $17 million (or 10.2%) and the rest-of-the-world with $10.5 million (or 6.3% of the total).

In the view of the industry insiders and practicing neurointerventional radiologists, relatively modest volume of life-saving cerebral thrombectomy procedures and corresponding product sales appear to reflect still insufficient body of favorable clinical data and inhibiting impact of the published dubious findings from the major IMS-III study.

The latter compared first-generation cerebral thrombectomy techniques with standard medical (and tPA) therapy and asserted that endovascular clot retrieval interventions did not result in visible improvement in patient outcomes. The cited conclusions clearly contradict results of numerous randomized trials with available second-generation cerebral revascularization systems, which appear to documented superiority of the latter system in management of acute ischemic stroke caseloads.

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.

Based on these assumptions, the cumulative worldwide volume of cerebral thrombectomy procedures is projected to experience accelerated growth to the end of the forecast period resulting in 10.8% overall average annual expansion of corresponding interventions in the forthcoming five years to an estimated 56.2 thousand total procedures worldwide in 2019.

From: “Emerging Global Market for Neurointerventional Technologies in Stroke, 2014-2019”, Report #C310.

The worldwide market for cerebral clot retrieval systems is forecast to grow at a slightly slower pace expanding on average 10.1% per annum to about $268.4 million in the year 2019. Price pressure will keep sales growth lower than procedure volume gains.

The largest absolute dollar gains can be expected in the U.S. market (which is projected to add $55.9 million in corresponding device revenues), followed by the West European marketplace (+ $30.6 million), major Asian state business (+ $11.2 million) and the rest-of-the-world (+ $4.7 million).

Medtech Fundings in October 2016

Fundings in medical technology during the month of October 2016 stand at $262 million, led by the $75 million funding of AcuFocus, Inc.

The complete list of fundings for the month thus far is at link.


For a historical listing of fundings by month, see link.

Technologies at Recent Medtech Startups

Below is a list of the technologies under development at medical technology startups identified in October 2016 and included in the Medtech Startups Database:

  • Neuoro-stimulation via patch.
  • Epinephrine auto-injector
  • Portable ultrasound device to detect the occurrence of strokes.
  • Medication adherence device to facilitate self-injection.
  • Diagnosis of malaria and sickle cell.
  • Implant devices to fight biofilms and infection.
  • Technologies to address infection and other risk in nursing protocols.
  • Electronic bone depth gauge for use in orthopedics.
  • Peripheral chronic total occlusion device.
  • Deep learning and artificial intelligence in point of care ultrasound.
  • Quantitative transmission ultrasound.

A historical listing of technologies at medtech startups (through January 2016).

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.
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
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
V.A.C. Ulta
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 2024MedMarket Diligence, LLC.

Cardiac Rhythm Disorders and Implantable, Device-based Treatments

Cardiac rhythm disorders, also called arrhythmias or dysrhythmias, encompass a variety of relatively common acute and chronic conditions characterized by recurrent distortions in the electrical and contractile activity of the heart, which may cause clinically significant and progressive hemodynamic deficits and cardiopulmonary impairment.

According to the available statistics from the American Heart Association (AHA) and Heart Rhythm Society, symptomatic cardiac arrhythmias effect over 10 million Americans and account for approximately 20% of all chronic conditions treated by cardiologists in the United States.

The rate and rhythm of the heart are determined by the intrinsic rhythmicity of special tissues and structures within the heart wall muscle generated by the heart’s natural electrophysiological mechanism. Normal cardiac rate and rhythm ensure continued uninterrupted blood flow an associated supply of oxygen and nutrients to the brain and other vital organs. Irregularities in the rate, rhythm, or origin of a stimulus leading to myocardial contraction can potentially interrupt normal blood circulation, causing inadequate function of important body systems, stroke or sudden cardiac arrest and death. Heart pacing disorders usually degenerate and worsen over time.

Although cardiac arrhythmias may be triggered by congenital heart defects, in which the electrical system of the heart does not develop properly, non-congenital heart disorders are believed to be the most common causes of chronic arrhythmias. The latter is particularly true for ischemic heart disease, which results in reduced blood flow and oxygen delivery to heart tissue, and heart tissue scarring typically caused by myocardial infarction. Other causes of arrhythmia include abnormal blood and tissue concentrations of certain minerals; abnormalities of the autonomic nervous system, which is involved in cardiovascular regulation; stress; and use of alcohol, caffeine, illicit drugs, and tobacco, as well as diet pills and some other medications.

Cardiac arrhythmias are generally categorized according to their impact on heart rates. Bradycardia is an abnormally slow resting heart rate, whereas tachycardia is an abnormally high resting heart rate. Bradycardias are most commonly associated with SA node disease and/or various forms of heart block.

Tachycardias are usually classified by their origination site and may be subdivided into two broad categories, specifically, supraventricular tachycardias (SVTs) and ventricular tachycardias (VTs).

Below are shown the projected implantable pump generator placements by region from 2015 to 2022. These include pacemaker placements, implantable cardioverter defibrillator placements, and cardiac resynchronization therapy placements.


Source: MedMarket Diligence LLC (Report #C500).

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


Source: MedMarket Diligence, LLC; Report #V201.

Wound management is highly fragmented and competitive

The wound care industry is highly fragmented, with around eight large companies leading the pack, but with hundreds—some say thousands—of small cap companies also manufacturing and marketing wound care products. The space is attractive, because even small companies can experience a sudden rise in market share and profits if they are able to develop a medical manufacturing breakthrough.


Source: Report #S251.

This market has a low level of concentration, meaning that no single global company, a list that includes Johnson & Johnson, Acelity LP, Inc., 3M Health Care and Smith & Nephew, dominates the market. Another half-dozen manufacturers have less than 10% market share, while ‘Others,’ which represents the hundreds of additional companies active in this space, accounts for the largest share of the wound care market. The field is crowded and highly fragmented. Barriers to entry vary by product, with the traditional segments having relatively low barriers to entry, while Growth Factors, for example, requires the potential manufacturer to possess specific, highly-technical information and physical equipment in order to enter the field.

To take a couple of examples of the high density of manufacturers in these product segments, the Foam Dressings segment includes 3M, B. Braun, BSN Medical, Coloplast, ConvaTec, Covalon Technologies, Medtronic, Derma Sciences, Hartmann Group, Hollister and many more. In the multimillion dollar NPWT industry, key players include Smith & Nephew, wound care specialists Kinetic Concepts (KCI, now owned by Acelity LP, Inc.), Prospera, Talley Group Ltd, Convatec, Mölnlycke Health Care AB, ArjoHuntleigh Healthcare Ltd, Medela, Inc., and Genadyne.

From, “Wound Management, Forecast to 2024: Established and Emerging Products, Technologies, and Market in the Americas, Europe, Asia/Pacific, and Rest of World.” Report #S251.

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:


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.


Source: Report #C500.

Materials used in sealants, glues, and hemostats

Sealants are most often used to stop widespread, diffuse internal bleeding. The product may be sprayed on a bleeding surface, or applied internally using a patch. Sealants are considered inappropriate for heavy bleeding. Surgical sealants may be made of glutaraldehyde and bovine serum albumin, polyethylene glycol polymers, and cyanoacrylates. Fibrin sealants are made of a combination of thrombin and fibrinogen. Sealants may also be made from a patient’s blood (autologous), which limits immunological and other risks.

Although the terms ‘glues’ and ‘adhesives’ are frequently used interchangeably, medical glues are products used to make two tissue surfaces adhere securely to each other without coming apart under normal physical stress. The definition of medical glues does not include medical adhesives such as those coating a bandage to make it stick to the skin.

A hemostat is commonly used in both surgery and emergency medicine to control bleeding, such as from a torn blood vessel. 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 putty that may be applied to the bleeding area. Mechanical hemostats, which generally require pressure to stop the bleeding, include items such as hemostatic clamps, absorbable gelatin sponge, collagen, cellulose, or polysaccharide-based hemostats applied as sponges, fleeces, bandages, or microspheres, and do not contain thrombin or any other active biologic compounds.

Global Market for Wound Sealants, Glues and Hemostats, 2015-2022


Source: “Worldwide Markets for Medical and Surgical Sealants, Glues, and Hemostats, 2015-2022.” (report #S290.)

Coronary and Peripheral Vascular Dominate Global Cardiovascular Procedure Volumes

In 2016, the cumulative worldwide volume of the cardiovascular device 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).


Source: Global Dynamics of Surgical and Interventional Cardiovascular Procedures, 2015-2022.