CD&D
and CD&Ds

England’s influential National Institute for Health and Clinical Excellence (NICE) has reversed its earlier position opposing use of drug-eluting stents (DES), clearing the way for reimbursement of such interventions in what is estimated to be a $100 million market. If there are no appeals against the draft decision, the final guidance on DES will go into effect in March.

The $750 price difference between bare-metal stents (BMS) and DES in England and Wales are at the heart of the institute’s concerns. NICE unleashed a storm of controversy in August of last year when it published draft guidance saying DES does not “represent a cost-effective use of National Health Service resources” compared to BMS.

With the new draft guidelines, the institute removed the cloud that was hanging over DES use in the UK with a flat endorsement for patients who are deemed at risk of undergoing follow-on surgeries if a conventional BMS were implanted. NICE defines these patients as having a coronary artery less than 3 mm in diameter, where the segment of the artery to be treated is longer than 15 mm.

Offering a comprehensive review of 17 studies and 11 different DES devices, the NICE appraisal committee concludes that revascularization rates were reduced by about three-quarters compared with BMS, consistent across most studies.

NICE recommends reimbursement for DES devices that do not cost £300 ($597) more than a BMS device. The price for a DES can range from £233 ($463) to £1,225 ($2,437), according to nine economic evaluations included in the assessment. And a report from the Dow Jones wire service cites a recent survey placing the current premium around £380 ($756). The recommendation for reimbursement is expected to exert a downward price pressure on DES manufacturers.

While the UK is a smaller market for DES, other governments and insurers, such as Germany’s 300-plus health funds, closely follow the publicly available guidance and best-practice recommendations.

Medical Simulation launches training for Edwards’ Sapien valve

Medical Simulation (Denver), a provider of medical training and education services, last month reported launching the Edwards Sapien Transcatheter Heart Valve (THV) training program in Europe. Edwards Lifesciences (Irving, California) received CE-mark approval for its Sapien transcatheter aortic heart valve with the RetroFlex transfemoral delivery system last September, and the CE mark for the Sapien valve with the Ascendra transapical delivery system in December.

Medical Simulation said it has worked with Edwards since 2004 to develop a comprehensive THV procedure training program for surgeons and cardiologists during U.S., Canadian and European clinical trials. With CE-mark approval in Europe, the program is now focused on providing commercial product training for physicians that includes online training, an advanced combination of didactic and simulation education integrated with cases studies and hands-on product education with expert physician proctoring.

Medical Simulation’s SimSuite simulation technology integrates the THV product into a comprehensive patient simulator, allowing physician trainees to conduct the procedure as close to real life as possible, including managing early learning-curve complications that the company said can now be avoided with proper techniques learned in the clinical trials.

Edwards’ Sapien THV integrates balloon-expandable stent technology that leverages the company’s bovine pericardial tissue and 30 years of design and manufacturing expertise. The Sapien is compressed onto a balloon to the approximate diameter of a pencil and then either threaded through the patient’s circulatory system from the leg (transfemoral delivery) or inserted between the ribs (transapical delivery) and deployed across the patient’s diseased aortic valve — all while the heart continues to beat.

In both cases, the procedure is completed without open-heart surgery or cardiopulmonary bypass, providing a treatment option for patients considered high risk for traditional open-heart surgery.

Medical Simulation provides training and education services to medical product manufacturers, medical societies, and hospital personnel, including clinical specialists, sales representatives, physicians, nurses, and technicians.

Genous R stent garners high marks in study in Italy

Patients who received the Genous Bio-engineered R stent, a pro-healing stent from OrbusNeich (Hong Kong) had significantly fewer major cardiac adverse events (MACE) than patients who received Boston Scientific’s (Natick, Massachusetts) Taxus or Johnson & Johnson’s (New Brunswick, New Jersey Cypher drug-eluting stents in a study conducted at Federico II University of Naples (Naples, Italy). The study involved 195 high-risk patients who underwent percutaneous coronary intervention with either Genous or Cypher/Taxus implantation at the university’s cath lab.

At 10 months’ follow-up, the cumulative MACE rate for the Genous group was 4% vs. 22% for the combined Taxus and Cypher group. For the MACE components, the cumulative rate of target vessel revascularization was 1% for GRS vs. 11.8% for DES, the cumulative rate of myocardial infarction was 1% for GRS vs. 7.8% for DES, and the cumulative mortality rate was 2% for GRS vs. 7.8% for DES. In addition, the cumulative rate for stent thrombosis was 2% for GRS vs. 5.8% for DES.

The Genous stent is coated with an antibody to capture a patient’s endothelial progenitor cells (EPCs), which OrbusNeich said “accelerates the natural healing process.”

EPCs circulate in the bloodstream and are involved in the repair of blood vessels. “When attracted to the surface of the Genous stent, EPCs can form an endothelial layer over the stent to provide protection against thrombus and minimize restenosis,” the company said.

1st standardized cardiac pacing exam issued in Japan

The International Board of Heart Rhythm Examiners (IBHRE; Washington) has issued the first standardized cardiac pacing exam for Japanese allied professionals. This marks the first time the IBHRE exam, considered a key benchmark of professional competency in cardiac pacing, defibrillation and electrophysiology, will be tailored to the needs of a global healthcare system outside of the U.S.

IBHRE said it hopes its partnership with the Japan Heart Rhythm Society (JHRS) will serve as the model for future exam tailoring and administration in countries such as China, Russia, and India.

The knowledge base of the exam, which includes device functions, is for the most part a global standard, IBHRE said. However, it said patient management questions and an understanding of the clinical culture and medicines used in Japan “were considered when tailoring the exam.”

The organization said translation also was taken into account, as word usage and meanings may differ.

The IBHRE said the Japanese Ministry of Health has mandated that in addition to allied professionals, sales representatives, technical advisors and anyone else having contact with patients from the medical device industry must be certified.

More than 7,000 individuals in the U.S. have taken the IBHRE exam to date. Nearly 645 allied professionals in Japan already have signed up to take the computer-based test. Results will be announced in March.

IBHRE is an affiliate, but independent, body of the Heart Rhythm Society (HRS; Washington).

Occlutech, AGA differ on patent ruling by AIPPI

Occlutech (Jena, Germany) a manufacturer of coronary occlusion devices said it has obtained approval for its IP position in relation to patents held by AGA Medical (Minneapolis) from the European International Association for the Protection of Intellectual Property (APPI).

AGA — claiming ownership of European patent (EP 0 808 138) registered in Germany for intravascular occlusion devices and the method of forming or manufacturing these medical devices — said that Occlutech misrepresented the role of AIPPI, saying that AIPPI is simpply a trade association, “not an adjudicatory body”.

AGA’s original action against Occlutech, filed in Dusseldorf in August 2006, requested damages against Occlutech, Drabo Medizintechnik (Cologne, Germany) and their CEOs and further requested a permanent injunction prohibiting them from manufacturing and marketing the infringing “Figulla Occluder” line of products. AGA said that the three-judge panel held that Occlutech and Drabo infringed AGA’s patent and granted AGA the right to enforce an order prohibiting the defendants from any manufacture, possession or sale of its infringing products.

During the original grant procedure, however, the Examiners of the European Patent Office did not accept the broad scope of the claims. This created significant reason for Occlutech to appeal the first instance district court’s decision that Occlutech literally infringe the AGA patent in Germany and to initiate non-infringement proceedings in several other European countries.

Occlutech asked AIPPI for an independent opinion, and Robert Moszner, CEO of Occlutech, said that its opinion “strongly supports our view that we are not infringing the patent brought forward by AGA Medical. We have developed a unique technology that is surrounded by its own strong intellectual property and we look forward to having our position confirmed in European and U.S. National courts.”

AGA, however, called these statements “false and misleading,” promising that it would explore remedies under German law to prevent further “misrepresentations” ‘by Occlutech.

Occlusion devices are used to treat structural heart defects and abnormalities such as Atrial Septal Defects (ASDs) and Patent Foramen Ovale (PFOs) in a minimally invasive, non-surgical way.

The market for PFO occluders in particular is expected to expand significantly as the link between PFO and strokes, as well as severe migraine, becomes increasingly well-documented.

CardioDynamics in accord with equipment firm in India

CardioDynamics (San Diego), developer of the Impedance Cardiography (ICG) technology, reported a strategic alliance with Recorders and Medicare Systems (RMS; Chandigarh, India), one of the largest manufacturers of medical equipment in that country.

Under terms of the distribution and technology licensing agreements, RMS will have rights to sell CardioDynamics’ BioZ products in India and also will integrate BioZ ICG technology into its own patient monitoring products.

RMS is a manufacturer and seller of electro-medical equipment to the Indian healthcare market. The company says it has product installs in nearly every major medical institution in India and has more than 200 sales and service personnel based in 53 branch offices throughout the country.

CardioDynamics will receive product revenue for each ICG monitor and a licensing fee for each BioZ ICG kit purchased by RMS.

Michael Perry, CEO of CardioDynamics, said, "We have made a concerted effort to diversify our business beyond the U.S. physician office market, which is heavily dependent upon Medicare and private insurance reimbursement. These agreements with RMS are another step in driving our international growth initiatives and will build upon the recently announced record 50% year-over-year quarterly growth in our international business.

"Through our technology licensing strategies, we are increasing global access to our BioZ ICG technology and increasing the recurring revenue content of our business."

CardioDynamics said India, with its population of more than 1 billion, "has significantly increased its healthcare expenditures over the past decade to more than $34 billion or roughly 6% of GDP. The population of individuals at least 60 years of age is projected to triple over the next 20 years to an estimated 190 million."

Leman reports successful animal studies of heart valve

Leman Cardiovascular (LCV; Morges, Switzerland), which is focused on developing a third-generation heart valve, said it has successfully completed animal studies to evaluate the in vivo safety, performance, healing and handling characteristics in both the aortic and mitral positions of its heart valve. The company said results of testing showed increased performance over other products, less energy loss in blood cardiac throughput and a 100% survival rate at 90 days.

LCV said its heart valve "is designed to maximize blood flow and requires less work to accommodate any given cardiac output. The internal supports are placed in a manner to achieve a restoration of the native anatomy at the inflow of the valve; this allows the stress-free preserved leaflets to function in a manner mimetic of a natural valve."

The company said the new data show that animals in which the LCV valve was implanted show an average of 120% increase in hemodynamic studies over existing stented valves.

"The animal study results are really very encouraging and show the product holds strong promise," said Richard Bianco, head of the experimental surgical department at the University of Minnesota (Minneapolis) and an expert in cardiac valve testing, who has been involved in the development of many other valves on the market today.

LCV said the study was conducted according to ISO/FDA 5840:2005 norms and 100% of the animals operated upon survived; moreover, they showed a faster recovery than usually observed.

"In this study we demonstrated that LCV’s third-generation heart valve delivers in terms of performance, flow characteristics and durability," said Benedict Broennimann, CEO of LVC. "The procedure with our valve is shorter than average. The next step will be first in man, which we plan to do by the end of the first semester 2008."

The valve design is based on a concept invented by heart surgeon Afksendiyos Kalangos, MD, head of the department of cardiac surgery at University Hospital (Geneva, Switzerland), and developed together with other heart valve experts.

The design is protected by three patents, LCV said, and "combines all the advantages of biological stented and stentless valves without their disadvantages, providing ease of implantation with high performance."

The U.S. subsidiary of LCV, Hancock Jaffe Laboratories (Irvine, California), markets the ProCol Vascular Bioprosthesis for the creation of a bridge graft in patients with end-stage renal disease requiring vascular access for dialysis in the U.S., and is developing other types of biological devices.

CoreValve reports enrollment under way for trial of ReValving system

CoreValve (Irvine, California) said that the expanded clinical evaluation of its ReValving system for percutaneous aortic valve replacement in high-risk patients with aortic stenosis is enrolling patients at 32 sites in 11 European countries.

The ReValving system procedures can be performed under local anesthesia, without the need for surgical cut-down or repair, and without hemodynamic support or artificially accelerating the heart rate.

The ReValving bioprosthesis, designed for transcatheter delivery, now has positive follow-ups out to nearly three years in this patient population, Core Valve said.

ART leases space for bioresorbable stent manufacturing

Arterial Remodeling Technologies (ART; Paris) reported leasing a 20,000-square-foot manufacturing facility as a result of mastering its polymer-based manufacturing technology to produce bioresorbable stents.

The company said those bioresorbable stents are designed to dismantle in vivo over an optimized time horizon, “thus allowing the body’s natural arterial remodeling process to occur, which is normally restricted by the deployment of permanent metallic stents.”

ART is developing bioresorbable peripheral and coronary polymer stents that promote the natural remodeling of an injured artery after angioplasty. Its technology is based on intellectual property originating from the Cleveland Clinic; the French national research institute, Centre National de Recherche Scientifique (Montpellier); and Necker University (Paris).

BioSensors BioMatrix DES cleared for sale in Europe

The technology behind a new bio-absorbable drug-eluting stent (DES), licensed by four companies, has received CE-mark approval, clearing two of the stents for sale in most European countries. These stents offer an alternative to the troubled DES market that saw a dramatic 23% drop in usage of DES devices last year following reports of thrombosis and death among those DES-implanted.

BioSensors International (Singapore/Newport Beach, California), which holds the license for three key features of the new stent, reported last month that its BioMatrix stent had received the long-awaited approval and said it would immediately launch sales in the approved markets, which include certain Asian, Middle Eastern and Latin American markets that also recognize the CE mark.

The BioSensors announcement on Jan. 17 was upstaged the day before by Terumo (Tokyo), which said it received the CE mark for its Nobori stent, built with the same s-scaffold design featuring a biodegradable polylactic acid polymer (PLA) that releases Biolimus A9, an anti-restenotic drug that has proven less aggressive than therapeutics eluted by current market-leading stents.

Terumo holds an exclusive license on the BioMatrix technology in Japan and non-exclusive rights elsewhere, excluding the U.S. Terumo Europe (Leuven, Belgium), which markets the Tsunami bare-metal stent (BMS) and the company’s Axxion DES, said it expects to launch sales in more than 20 countries during 1Q08.

As the year began, Xtent (Menlo Park, California) said it had submitted an application for its Custom NX DES to the European notified body designated for CE-mark approval and said it expects to begin commercial launch in the second half of this year. The Custom NX is based on the BioMatrix technology, which Xtent has licensed from Biocompatibles.

Devax (Irvine, California) reported in mid-December that it had completed patient enrollment in the DIVERGE clinical trial evaluating its Axxess stent that licenses Biosensor’s drug and polymer for a self-expanding nitinol stent engineered for the treatment of coronary and vascular bifurcation lesions. Bifurcation lesions are areas of atherosclerotic disease that occurs at a location where one large vessel divides into two smaller vessels, in an estimated 20% of all patients worldwide undergoing stenting procedure.

• St. Jude Medical (St. Paul, Minnesota) reported receiving CE-mark approval of two integrated components — the Cool Point Irrigation Pump and the IBI-1500T11 Cardiac Ablation Generator. The company said the products are designed “to enhance physicians’ ability to perform successful cardiac ablations, [and] were developed for use together with the St. Jude Medical family of Therapy Cool Path irrigated catheters.”

The pump’s tubing includes an in-line occlusion detector that monitors flow pressure between pump head and catheter tip, providing an alert if flow pressure increases substantially relative to the flow rate – an indication that irrigation ports on the catheter tip may be blocked.

The new generator is programmed for automated communication with the pump. The integrated pump and generator accommodate the Therapy Cool Path family of open-irrigated catheters, which are designed to maintain lower tip-to-tissue temperatures, thereby creating wider and deeper lesions.

St. Jude said the Cool Path family was recently expanded with the CE-mark approval of the Cool Path Duo irrigated ablation catheter, designed for uniform cooling of the entire length of the tip electrode.

• Tryton Medical (Newton, Massachusetts), a developer of stents designed for the treatment of bifurcation lesions, said it has received the CE mark for its Side-Branch Stent. The Side-Branch product is a cobalt-chromium, balloon-expandable coronary stent developed, the company said, “for the treatment of the entire spectrum of coronary artery bifurcation disease.”

Tryton said about 540,000 procedures are performed annually to address bifurcation lesions, accounting for 20% of all coronary lesions treated. It said that “no other dedicated solution exists today that fully addresses these lesions.”

Results of the Tryton 1 (First-In-Man) Study were presented by Patrick Serruys, MD, of the Thoraxcenter at Erasmus University Medical Center (Rotterdam, the Netherlands) and Ralf M ller, MD, of Helios Heart Center (Siegburg, Germany).

When the Tryton cobalt chromium BMS was used with a standard DES (Cypher Select, Taxus or Xience V), no side branch restenosis was observed in the 30 patients treated.

H. Richard Davis, chief technology officer of Tryton, said a market launch of the stent is planned for May in conjunction with the EuroPCR meeting in Barcelona.

• Boston Scientific (Natick, Massachusetts) reported receipt of the CE mark for its Cognis cardiac resynchronization therapy defibrillator (CRT-D) and Teligen implantable cardioverter-defibrillator (ICD). The two products are among the world’s smallest and thinnest high-energy devices, at 32.5 cc and 31.5 cc respectively, while less than 10 mm thick, according to Boston Scientific.

The company said that both devices offer features based on significant engineering advances, including extended battery longevity, self-correcting software and improved programming technology.

• Concentric Medical (Mountain View, California) reported receiving European regulatory clearance for its Merci L4 and Merci L6 Retrievers. These new Retrievers, released in the U.S. last year, join the existing Merci Retrievers already on the market in Europe, providing physicians with additional choices in their efforts to restore blood flow in ischemic stroke patients, the company said.

The Merci Retriever, a shaped wire constructed of nitinol that allows delivery of the Retriever in linear form, using standard catheterization techniques, is designed to restore blood flow by engaging, capturing and removing blood clots. A small puncture in the groin is used to introduce the Merci Retriever into an artery leading to the brain. Upon reaching the targeted area, the Merci Retriever is deployed and returns to its original helical shape.

The Merci L6 Retriever has a 2.7 mm cylindrical helix and is designed for use in larger vessels than the Merci Retrievers currently on the European market. The Merci L4 Retriever has a 2.0 mm cylindrical helix and is designed for use in smaller vessels.

• PLC Systems (Franklin, Massachusetts) said its RenalGuard System received the CE mark, clearing the way for the company to begin its initial launch of the product in the European Union. RenalGuard is an automated, real-time, matched-fluid replacement device intended for interventional cardiology and radiology patients undergoing imaging procedures using contrast media. It is based on existing pre-clinical study data that suggests that initiating and maintaining high urine output during imaging procedures allows the body to rapidly eliminate toxins in contrast media, reducing their harmful effects.