CDU Contributing Writer
PARIS Conference leaders initiated a new feature at the 14th European Paris Course on Revascularization (EuroPCR), held here in late May. Ten emerging companies were selected from among many contenders based on the innovative nature of their cardiovascular technologies and the clinical solutions they provide. Months prior to the prestigious annual meeting, interested companies submitted a dossier on their technologies for review by the Scientific Committee of Physicians and board of directors led by Professor Jean Marco of Clinique Pasteur (Toulouse, France). At a well-attended session that was part of the official course program, each selected company was invited to present a five-minute overview on its technology, clinical results and intellectual property, followed by a question-and-answer session. Since EuroPCR consistently attracts 8,000 physicians and senior-level executives from more than 80 nations interested in leading-edge technology, this forum spelled opportunity for those firms chosen to showcase their innovative efforts.
Raoul Bonan, MD, of Institut De Cardiologie de Montreal (Montreal, Quebec), emerging technology chairman for the conference, moderated the session and challenged the presenters by consistently asking tough questions. Bonan commented how emerging companies can provide either a significant improvement to existing technology or "a fundamentally new therapy or even a new diagnostic system that will help endovascular clinicians." Our overview of the 10 companies selected by EuroPCR includes a description of their technology, animal and clinical data and important business issues.
Evalve: Percutaneous mitral valve repair
Mitral regurgitation is a condition where disease or injury has caused the heart's mitral valve to leak, compromising the intended one-way function of the valve. Mitral regurgitation leads to increased size of the left ventricle and eventually leads to congestive heart failure (CHF). Over the next decade, percutaneous valve repair and even replacement is expected to revolutionize the clinical landscape of cardiac valve disease treatment. Don Baim, MD, of Brigham and Women's Hospital (Boston, Massachusetts), a scientific advisor to Evalve (Redwood City, California), presented the Evalve percutaneous approach to mitral valve repair.
Replacement and repair of mitral valves during open-heart surgery has shown improved patient outcomes but has been associated with high mortality and morbidity. As shown in the Society of Thoracic Surgeons' (Chicago, Illinois) most recent U.S. Incidence of Complications Database, from 1997, the incidence of death for mitral valve repair or replacement is relatively high: 2.3% for repair and 5.6% for replacement. The prevalence (4 million) and annual incidence (250,000) of people with significant mitral regurgitation is substantial. However, only about 40,000 mitral valve surgeries are performed in the U.S. annually because of the significant risk and trauma associated with the open, stopped-heart procedure. The emergence of endovascular techniques is in response to the desire for mitral valve repair with acceptable low operative risk, increased patient comfort and accelerated recovery.
The Evalve procedure uses a catheter-based approach, performed by interventional cardiologists to perform the surgically proven technique of suturing the mitral valve leaflets together in the center to reduce regurgitation (referred to as the Alfieri, or edge-to-edge technique). This surgical technique has been effectively used to treat both structural and functional mitral regurgitation. The catheter is designed to place a clip on the valve leaflets while the heart is beating normally. The clip can be temporarily closed to evaluate mitral regurgitation and if desired can be repositioned until a satisfactory result is achieved. The clip is then detached from the catheter. Chronic animal studies and bench tests, including cycle fatigue testing of the clip, are complete and showed favorable results.
The Phase I EVEREST (Endovascular Valve Edge-to-Edge Repair Study) prospective multi-center clinical trial is being initiated at several U.S. sites. This study will evaluate safety and efficacy in both structural and functional mitral regurgitation. Percutaneous repair is achieved using a transseptal puncture without stopping the heart or using cardiopulmonary bypass or surgical opening of the thoracic cavity. The clinical trial also will assess the ability to monitor and repair the mitral regurgitation during the procedure and reposition or reverse deployment as needed if a successful correction cannot be achieved by repositioning.
CoreValve: Percutaneous valve replacement
Five million Americans have been diagnosed with valvular heart disease. As explained above, in some cases repair is possible. However, each year about 300,000 patients throughout the world have heart valves that are beyond repair and have to be replaced. The global market for valve replacement was estimated at close to $1 billion in 2002. Table 1 shows the heart valve market size and trends. According to the American Heart Association's (Dallas, Texas) 2003 Heart and Stroke Statistical Update, valvular heart disease is responsible for nearly 20,000 deaths each year in the U.S. and is a contributing factor in about 42,000 deaths. The majority of these cases involve disorders of the aortic valve (63%) and the mitral valve (14%).
Today, when a valve stenosis (diseased valves that do not fully open and close) has reached a critical state, or when aortic valve regurgitation (valves that do not close properly) is severe, a major open-heart procedure is required. (Mitral valves can often be repaired, whereas aortic valves usually are replaced when treated.) During the surgical procedure, the malfunctioning valve is cut out and replaced with one of the two types of replacement valves available today: mechanical or tissue (biological), which does not require lifelong anticoagulation to prevent a blood clot.
To initiate open-heart valve repair, the sternum is sawed open, creating a 10-inch gap yielding access to the heart. The heart is stopped during critical parts of the operation. This procedure takes two to three hours, requires one to two days in an intensive care unit, a hospital stay of five to seven days and typically costs about $30,000. Due to the severity and discomfort of the open-heart procedure, many patients who are diagnosed and have been recommended to receive a new valve wait for further progression of the illness to undergo surgery. In addition, because of old age and advanced cardiac or other comorbidities, many patients are not operable with the current open-heart technique and are thus contraindicated for heart valve replacement.
Jacques Seguin, MD, a French cardiovascular surgeon with more than 20 patents in the cardiac device field, designed and developed CoreValve, a coronary valve allowing for percutaneous replacement. CoreValve (Paris) offers a novel percutaneous valve that incorporates a multilevel self-expanding biocompatible metal alloy stent. The self-expanding stent provides controlled expansion and positioning during deployment while maintaining blood flow. Like a surgical prosthesis with a specific element designed to receive the sutures holding the prosthesis in place, the lower-level stent anchors the valve ring to the annulus ensuring a tight connection to the anatomy, even if the area is not tubular. The higher second-level stent allows the valve leaflets to open and close in line with the coronary sinuses (mimicking the surgical procedure) and is designed for flexible support and optimum valve leaflet function. CoreValve said it believes that its technology may be adapted to other biological valves currently marketed and is developing a delivery system to support this desired activity.
CoreValve said it anticipates that among patients currently indicated for valve replacement surgery, up to 10% could be treated by endovascular methods within the next five years. In addition, it is anticipated that patients at high risk or contraindicated for surgical valve repair or replacement may be candidates for an endovascular procedure further expanding the market (Lutter, Journal of Thoracic Cardiovascular Surgery, April 2002). Martin Leon, MD, of Lenox Hill Hospital (New York), has commented about the need for a percutaneous valve procedure: "A procedure that could be performed under local anesthesia in the cardiac cath lab would offer a tremendous alternative to these (heart valve) patients, many of whom have no options today."
CoreValve's intellectual property and stenting technology are designed for both aortic and mitral valve replacement. However, the company's initial focus is aortic valve replacement, which is a significantly larger market. CoreValve successfully completed a 14-sheep animal study in 1Q03. Additional animal testing is scheduled this year to fine-tune prosthesis design. CoreValve said it believes that its self-expansion property may provide increased durability over a balloon-expandable percutaneous valve such as that provided by Percutaneous Valve Technologies (Fort Lee, New Jersey), and is initiating clinical trials to substantiate that claim. The company projects European product launch in 2005.
FlowCardia: Recanalizations of CTOs
Chronic total occlusions (CTOs) are occlusions that have completely blocked blood flow in the coronary arteries for a minimum of several weeks and have historically shown less than a 50% success rate in being crossed or opened using conventional guidewire techniques. The CTO often is calcific and requires significant technical skill and time commitment to cross with current technologies and, in fact, many are not treatable at all in interventional laboratories. Due to the lack of effective drug therapy and the morbidity associated with open-heart bypass surgery, thus excluding high-risk patients, there have been several attempts by both large and small companies to develop an effective device to open CTOs in a minimally invasive fashion. CTOs represent one of the last great challenges in interventional cardiology. One estimate of prevalence (one or more CTO) in patients with multi-vessel disease is given as 48.5% (179/369) (Topol, Textbook of Interventional Cardiology, 1999).
FlowCardia's (Sunnyvale, California) device is a small, flexible catheter, called the Crosser, and is designed to recanalize a wide range of CTO lesion compositions. Compatible with any standard 0.014" guidewire, the Crosser converts alternating current to high frequency mechanical vibration to facilitate the recanalization of CTOs. Available in over-the-wire and monorail configurations, the energy is propagated to the tip of the Crosser catheter via a transducer. Less than 10 months after Series A funding from Frazier & Co. (Seattle, Washington) and JPMorgan Partners (New York), the Crosser CTO catheter was qualified, passed preclinical safety testing and has been successfully used in patients.
Eberhard Grube, MD, of Siegburg Heart Center (Siegburg, Germany) presented FlowCardia's CTO technology and spoke about the initial 15 cases using the device. Grube said, "The high frequency mechanical recanalization is a promising technology to help us solve the CTO problem. The Crosser system is easy to use. It fits very well into our standard technique, and does not complicate an already challenging procedure." Competitive technologies include those from Intraluminal Therapeutics (Carlsbad, California) and LuMend (Redwood City, California).
Pathway: Rotating expanding debulking catheter
Pathway Medical's (Redmond, Washington) CardioPath System combines dynamic aspiration for embolic protection with proprietary scraping blades for removal of a broad range of disease and thrombus in bypass grafts, CTOs and acute myocardial infarction (AMI). With millions of previous bypass patients who have implanted saphenous vein graphs (SVG) plus an additional 700,000 bypass procedures in the U.S. and Europe each year, just that segment of the intended market is significant. Unfortunately, more than 60% of SVGs develop significant blockages in the first 10 years after surgery. (Nishida, Journal of Invasive Cardiology, October 2000). With the advent of drug-eluting stents that reduce disease regrowth, interventionalists will consider the use of stents in more challenging vessels. This will further increase the market for a device that can safely remove disease and prepare the vessel for stent placement.
The 8 Fr compatible catheter, a clever engineering design with two sizes of cutting instruments on one device, is the first expandable device ever to be available to the market. The CardioPath catheter is able to expand the therapeutic cross-sectional area 100% over the device's initial size while inside the vessel. This allows the physician to create a small pathway initially, and then when rotational direction of the catheter is reversed, larger blades raise into position and cut a larger pathway.
The CardioPath System is designed to remove the obstruction as it advances through the vessel, which negates the need to cross the obstruction prior to treatment. The obstruction is removed with patented scraping blades. These blades apply the principle of differential cutting, whereby the healthy elastic tissue deflects away from the scraping blades but the diseased inelastic material is removed. This principle, similar to shaving a whisker while not cutting the underlying skin, allows the CardioPath System to remove all disease types ranging from hard calcium to soft plaque. The removed material, along with any thrombus, is aspirated through ports that are incorporated into the distal scraping blades and transported through the body of the catheter into a collection bag.
Greg Braden, MD, of Forsyth Medical Center (Winston-Salem, North Carolina), who delivered the Pathway Medical presentation, said, "The CardioPath catheter will be an important advance in interventional cardiology due to the capabilities in saphenous vein graphs and native arteries as well as a highly effective aspirating atherectomy catheter which may play a role in other acute coronary syndromes." CardioPath's clinical experience includes 25 saphenous vein grafts in the U.S. and 25 native arteries and SVGs outside the U.S. Results of the U.S. safety and feasibility study showed a 93% (26/28) procedural success, 14% major adverse cardiovascular events (MACE), 0% perforations and a mean procedural time of 56 minutes. An acute coronary syndrome/acute myocardial infarction feasibility study was initiated in Europe in May, and a trial directed toward receipt of the CE mark will begin in September.
Devax: Stent for bifurcated lesions
Treatment of bifurcation lesions (a blockage where an artery splits into two branches) remains a challenge for interventional cardiologists and is associated with high rates of complications and restenosis (Cervinka, Journal of Invasive Cardiology, December 2002). When treating a bifurcation lesion, the risk of side branch occlusion during angioplasty of the main branch is high and may be associated with myocardial infarction.
Estimates are that as many as 16% of 2.1 million coronary artery disease patients treated each year by interventional cardiologists worldwide present with lesions at bifurcated arteries. A significant portion of the patients with lesions at bifurcated arteries have not been able to be treated in the cardiac cath lab and had been referred for an open-heart procedure. The difficulty in using current endovascular devices such as angioplasty and stenting for treating lesions at bifurcated arteries is anatomical, since these devices are not designed to fit the "Y" shape of bifurcated vessels. The physician needs to maneuver multiple guidewires, intertwining several tubular stents attempting to cover the artery walls. Various techniques are used to accomplish this objective; one method uses a balloon to expand one stent to deform the shape of another, sometimes occluding blood flow to one branch. Additionally, as multiple stents are placed in this flared arterial segment, sections of the tubular stents can protrude into the artery, impede blood flow and lead to a blockage. The increased amount of metal in the artery has also been shown to cause a significant inflammatory response, again resulting in increased restenosis. A device specifically designed for lesions at bifurcated arteries may help to decrease the high rate of complications and restenosis and prevent some patients from requiring surgery.
The concept for the Devax (Irvine, California) self-expanding nitinol stent for treating coronary and vascular bifurcation lesions was developed by Jacques Seguin, serial cardiovascular device inventor cited above for development of a percutaneous heart valve. Seguin designed the concept for the Devax Axxess stent to conform to the natural anatomy of the bifurcation. One stent is a self-expanding flared stent that expands to the full width of the bifurcation and thus permits access to both side branches (hence the name, Axxess stent system). The Devax modular system also includes a second cylindrical stent for the side branch when clinically indicated (however any stent can be used in the side branch if desired). Both stents are delivered on separate rapid-exchange delivery systems compatible with standard 7 Fr guide catheters. The stent is designed to allow the physician complete access to both the main vessel and the side branch without adding to the procedural time and permits rapid deployment of additional stents or other interventional procedures for follow-on intervention when clinically indicated. Devax said it believes that the Axxess stent will deliver consistent desirable clinical outcomes due to the unique patented design specially developed for lesions in bifurcated arteries, the familiar techniques that allow rapid deployment with low pressure and minimal metal placed at the lesion.
As the principal investigator for the ongoing 70-patient European clinical trial, Siegburg Heart Center's Grube presented the concept of the CE-marked Devax Axxess stent and the data on the first 31 patients. Results showed no in-hospital major adverse cardiovascular events, zero out-of-hospital MACE at 30 days and 8% at 60 days. Procedural success and device success both were 97% and six-month angiographic restenosis of greater than 50% was 8%. Grube noted, "This is a modular approach because since the self-expanding flared shape allows open access to both side branches, you can decide if you want to add stents distally to the one that you have deployed according to the primary result." Commenting about his early concerns with self-expanding stents in the coronary arteries, Grube said, "Looking back at some self-expanding coronary stents that we had been using, we were a little bit afraid of jumping. That in fact is not the case. Since the design engineers have done terrific work, you have complete control of the delivery."
Devax received FDA investigational device exemption (IDE) approval for its 171-patient premarket approval trial in the U.S. in May. It also has filed for a 510(k) application for approval of the Axxess stent for use in the biliary and expects approval late this year.
The question has been raised about using standard stents with drug coating to reduce the rate of restenosis in lesions at artery bifurcations. However, as Ron Waxman, MD, of Washington Hospital Center (Washington), pointed out at last September's Transcatheter Cardiovascular Therapeutics conference, "High-risk groups such as bifurcated lesions have not performed well with current stents and a drug coating of sirolimus or paclitaxel." In results released at last November's American Heart Association scientific sessions, the 86-patient bifurcation feasibility study sponsored by the Cordis (Miami Lakes, Florida) unit of Johnson & Johnson (New Brunswick, New Jersey) showed that patients with bifurcated lesions who were treated with a Cypher stent had an overall in-segment restenosis rate of 21.9% at six months. Since the mechanical architecture of the Devax Axxess stent design conforms to the natural vasculature, discussion about the increased potential benefits of that stent with a drug coating are ongoing. Devax is involved with an evaluation of several anti-restenosis drugs with its stent design.
Competitive stents designed for treatment of bifurcation lesions include Advanced Stent Technologies (Pleasanton, California) and Guidant's (Indianapolis, Indiana) Multilink Frontier.
Conor MedSystems: Local drug delivery
Conor MedSystems (Menlo Park, California), founded in 1999, is a specialty drug-delivery company that develops stents and other medical devices as delivery platforms for controlled local delivery of a wide variety of therapeutic agents. Frank Litvack, MD, professor of medicine at the UCLA School of Medicine (Los Angeles, California) and president and CEO of Conor MedSystems, said: "Clinical outcomes data on current drug-eluting stents confirm that while they provide significant advantages, they are imperfect. Specifically, restenosis rates in high-risk patients, including diabetics, remain an issue. Further, vascular drug delivery indications beyond restenosis are now a possibility."
The first application, the Conor MedStent, is a drug-eluting coronary stent that has many tiny wells within the stent struts that can be filled with a single drug or combination of drugs. The design of the Conor system allows for "programmable" drug release, as each hole is filled with a polymer that acts as a controlled-release medium or to control directional release. It is this control over the timing or kinetic pattern of release and unique honeycombed design that also permits spatial distribution of the drug to achieve varying dosage levels at different points across the length of a stent. Currently, Conor uses a family of FDA-approved polymers that allows drug elution to span from a few hours to months. By using a range of different polymers, Conor said it believes it will be able to match the solubility properties of drugs with polymers to optimize drug dose and release kinetics. The company's initial focus is on the treatment of restenosis and vascular disease. It also is exploring additional markets where controlled drug release from a medical device may provide therapeutic advantages.
The MedStent is balloon-expandable and is 0.005" thick with a ductile hinge to preserve the integrity of the drug reservoirs during stent expansion. Since the drug is inside the stent vs. a polymer coating, the drug is not expected to crack or break off during either the crimping process or the insertion through tight lesions. It is designed to deliver a very uniform dose density along the axis of the stent with less than 3.5% to 5% variation throughout the length. The drug reservoir microstructures may make it possible to release one drug to the arterial wall (mural), and a second drug, isolated by a barrier layer inside the stent, could be released into the blood stream (luminal).
The PISCES trial (for Paclitaxel In-Stent Controlled Elution Study) is a feasibility study to evaluate variations in release rates and direction. The study includes 120 patients at four sites with four- and 12-month follow-up on the four different release kinetics. Two of the arms include both luminal and mural release, while two arms have just mural release. The trial is currently enrolling patients.
Litvack discussed the principal differences between the Conor MedStent and the Boston Scientific (Natick, Massachusetts) NirX Slow-Release stent used in the TAXUS II trial. Litvak said, "TAXUS II results showed an approximate 10% release of total drug loading in 10 days, with the residual amount remaining permanently on the stent. Conversely, the Conor MedStent includes the ability to vary release kinetics with the use of a fully bioresorbable polymer, which permits complete drug release in a specified period."
Volcano Therapeutics: Virtual Histology
Founded in 2001, Volcano Therapeutics (Laguna Hills, California) is an exceptionally well-funded, privately held company focused on the discovery, development and commercialization of products for the detection and treatment of atherosclerosis in the coronary arteries and peripheral vascular system.
Pauliina Margolis, MD, PhD, medical director of Volcano, discussed intravascular ultrasound. "Conventional intravascular ultrasound (IVUS) and MRI gives us structural information of the plaque, mainly the amount of plaque burden," she said. "Unfortunately, they don't give us any physiological information." Working with the Cleveland Clinic Foundation (Cleveland, Ohio), Volcano is developing spectral analysis technology, Virtual Histology IVUS, which may provide a better understanding of the composition of atherosclerotic plaques. By analyzing eight spectral parameters of the reflected ultrasound signal (in addition to amplitude, which generates gray-scale IVUS data and images), Volcano's Virtual Histology IVUS is designed to identify boundary features within the plaque and vasculature. With this data, the system may obtain additional information about the composition of atherosclerotic plaques, which could otherwise only be assessed at autopsy.
Image reconstruction, border detection and color categorized tissue classification are displayed on the instrument showing, for example, fibrous tissue green, necrotic tissue red, and calcium white. Based on histological correlation with fresh post-mortem histology (tissue studied within six hours of patient death), predictive accuracy was shown to be between 80% (fibrous) and 93% (calcified) (A. Nair, Journal of the American College of Cardiology, Supplement A, 2003). A pilot study at three European sites has collected data on 30 patients, and will soon be adding additional U.S. sites.
Since recent research shows that blocked arteries are responsible for no more than 15% of heart attacks and that 50% of heart attack victims actually have normal cholesterol levels, significant efforts are being extended by medical device manufactures to develop instrumention to identify the inciting agents of this life-threatening occurrence. The deadly culprits that appear to be responsible are the deposits of specific types of plaque embedded within the artery walls. Inflammation, now recognized as a central player in atherosclerosis, occurs when certain white blood cells, those that normally constitute the first line of defense against infection, invade the arterial walls and become active in tissue. The fatty pools become inflamed, swell and rupture without warning, releasing the lipid-rich necrotic core that can lead to blood clots, which may block blood flow to the heart causing a heart attack. Similar plaque deposits also reside in the carotid arteries and if erupted, can lead to stroke, the third-leading killer in the U.S.
Due to the volatile nature of these deadly lesions, pioneering physicians have labeled these lipid-embedded culprits "vulnerable plaque." This revised concept suggests new ideas for detecting and treating atherosclerosis. The inability of current imaging and other diagnostic testing methods to identify these lesions and even potentially deliver therapeutic solutions has opened a heated, well-attended race to the emerging technology finish line. Estimates are that the potential worldwide vulnerable plaque market for minimally invasive diagnostic procedures may exceed $3 billion by the end of this decade (Jan Wald, A.G. Edwards). The market for the treatment of vulnerable plaque is projected to be a further multiple of the diagnostic market. Table 2 on page 7 outlines some of the technologies under development, and the basis for the diagnosis and therapy.
Volcano also is working on a technology to identify vulnerable plaque using thermography catheters aimed to detect vessel wall inflammation. The premise is that vulnerable plaques, like all inflamed tissue, are hotter than surrounding normal tissue and that by measuring these temperature gradients, clinicians can determine the location and extent of the disease. The Volcano 3.5 Fr thermography catheter has a self-expanding basket with five arms, each with a temperature sensor, and one additional sensor in the center of the shaft to monitor blood temperature. The results are displayed on the instrument in graphic or numeric format.
Margolis discussed the safety studies on the Volcano thermography catheter conducted on 42 patients that included both stable and unstable disease states. Patients were followed for one week and did not show angiographic evidence of vessel wall dissections or thrombus formation after advancing the catheter to the distal position or as a result of the pullback. Of the first 24 patients analyzed, 13% had greater than 0.2 degrees Celsius increase in temperature, and 45% had totally stable arteries. The pilot study, targeted for seven European sites, will include data from acute coronary syndrome patients. A follow-on trial will target MI patients studied within six hours after plaque rupture. In addition, Professor Antonio Colombo of Centro Cuore Columbus (Milan, Italy), will begin enrolling patients this fall in a study aimed at correlating temperature measurements, histopathology and inflammatory biomarkers.
Companies with competitive vulnerable plaque detection technologies include Thermocore (Guildford, UK), LightLab (Boston, Massachusetts), Jomed (Rancho Cordova, California), Cardio-Optics (Boulder, Colorado), CardioStream (San Diego, California), InfraReDx (Cambridge, Massachusetts), Medispes (Zug, Switzerland), Magna-Lab (Syosset, New York) and Symbiotech Medical (Quebec).
IDev: Device incubator/accelerator
Innovation and development of next-generation interventional devices is the core concept behind the incubator/accelerator company IDev Technologies (Houston, Texas). More than 20 technologies were exclusively licensed from the M.D. Anderson Cancer Center (Houston, Texas); two have received the CE mark and one additional device is anticipated to receive the mark before year-end.
The first product is a 6 Fr adjustable, non-motor-driven mechanical thrombectomy device "designed to place procedural control back into the hands of the clinician," according to IDev Technologies CEO Jeffery Sheldon. Currently indicated for declotting of synthetic hemodialysis access grafts, testing and submissions are in process for approval in the peripheral vasculature and coronary arteries, among other applications. The catheter, named the AK nya Eliminator after its inventor, is radiopaque, offers directional control and uses three mechanisms of action: pulsatile, axial and rotational for the maceration of clots and clearing of thrombus.
The second CE-marked device from IDev, called the Texan, is a 5 Fr 0.018" guidewire compatible foreign body retrieval device intended for the removal or manipulation of inadvertently dislodged objects. The device features a variable loop design allowing for a type of "lasso" capture or manipulation of foreign bodies in vessels up to 30 mm in diameter without having to evaluate vessel and/or device size prior to the procedure.
The third product is a self-expanding nitinol biliary stent whose proprietary delivery system has been designed to be able to be repositioned if necessary. Placement accuracy is confirmed under fluoroscopic examination in the fully open state prior to release from the catheter. The delivery system is designed to offer the ability to reconstrain the stent and adjust placement prior to full release. The stent radial force is designed to be substantially greater than that offered by similar products on the market, and when combined with the "pre-deployment" capability, the company believes this may result in the elimination of the vessel pre-dilation prior to stenting.
Global sales will be accomplished through a combination of independent distributors and IDev sales representatives. A Canadian medical device license for the thrombectomy device was received in April and FDA approval on the product line is anticipated later in this quarter.
Protomed: Product design, development
Protomed (Marseilles, France) is a product design company dedicated to conceiving, developing and testing innovative medical devices for modern surgical procedures, with its strongest focus in cardiovascular biomechanics. One product under development is a suturing device for minimally invasive vascular surgery to replace knot tying. This device, conceived by a vascular surgeon, is designed to ensure safe locking of suture threads with a controlled and predictable tension. The technology has been engineered to be compatible with most classical suture threads and each closure can be removed if desired without risk to surrounding tissues.
Protomed focuses on developing novel solutions to improve surgery based on concepts from experienced clinicians, or for an existing company wanting to extend its product portfolio. Product development includes three main areas: 1) technical innovation, 2) accelerated product launch, and 3) confirmed quality. The company is able to execute technical innovation based on strong clinician proximity at each stage of development, allowing critical surgeon involvement from the idea to the prototype. In fact, Protomed's facilities reside within an experimental surgery center, which allows for valuable, ongoing feedback. Expedited development cycles are possible due to the broad range of capabilities resident within its staff, including comprehensive process analysis, review of competitive technology and integrated research and development. Quality engineering includes the validation and verification of a defined regulatory process and supporting documentation. The company has established a support network in France within the biomedical industry, including university and engineering schools.
Hemoteq: Biologic surface coatings
Hemoteq (Wurselen, Germany) designs, develops and licenses surface modifications for medical devices and diagnostic products. It offers eight different proprietary formulations to deliver hemocompatible, bioactive, hydrophilic and lubricious properties and also offer custom application assistance for developing new coatings. The coating techniques follow a similar format to the biologic coatings in nature and thus the company has labeled its technique "biomimicry." Drugs in a liquid state are attached to the device surface in ultrathin monolayers to deliver stability, predictable release-rate and drug-carrying capacity. Services also include specific drug-coating customization, prototype coating and large-scale clean room manufacturing. Hemoteq said it believes that medical devices coated with its nanocoating design are able to achieve product advantages in today's competitive market, with improved clinical outcomes.
The Hemoteq technologies make it possible to coat medical devices such as small-lumen vascular grafts, guidewires and all components of extracorporal circulation. The company's coatings include Camouflage, a hemocompatible coating that is a durable, covalently bonded complex carbohydrate that prevents activation of the coagulation cascade and results in anti-restenotic therapy. Another coating, Crescendo, is a semisynthetic biopolymer that enhances cell adhesion and growth. An additional coating named Lubriteq provides hydrophilic, slippery and hemocompatible characteristics.