CD&D and Staff Reports

Evalve (Menlo Park, California), a developer of devices for the percutaneous repair of cardiac valves, reported the first enrollment in the ACCESS-Europe study, a post-market observational study of the company's MitraClip therapy in Europe.

The MitraClip system is the first commercially available treatment option for non-surgical mitral valve repair for patients suffering from the effects of functional and degenerative mitral regurgitation (MR), which affects millions of people worldwide and is the most common type of heart valve insufficiency in Europe and the U.S.

In both Europe and the U.S., there are roughly 250,000 new diagnoses of significant MR each year; but only 20% of these patients undergo surgery each year. Evalve said, "Non-surgical patients and many of the higher risk surgical patients continue to be affected by the chronic volume overload caused by MR, which requires the heart to work harder, which may lead to heart failure and hospitalization."

The first patients were enrolled in ACCESS-Europe by a team led by Professor Corrado Tamburino, MD; Gian Paolo Ussia, MD; Salvatore Scandura, MD; and Sarah Mangiafico, MD, at Ferrarotto Hospital at University of Catania (Sicily, Italy).

"ACCESS-Europe will provide important clinical care and health economic information about the MitraClip therapy," said Tamburino, chair of cardiology, cardiology department, cardiac catheterization and interventional cardiology at Ferrarotto Hospital. "This data will allow us to further understand the benefits of the MitraClip therapy for patients with mitral regurgitation and the health economic benefits of a less invasive alternative for patients suffering from MR."

The ACCESS-Europe study will evaluate the MitraClip therapy in the continuum of care available to patients with MR. Patients will be evaluated at baseline through 12 months after enrollment. As many as 20 institutions within Europe will participate and up to 300 patients treated with the MitraClip device will be enrolled.

In addition, information will be collected in two comparator groups, one which includes medically managed heart failure patients with MR and another which includes patients who are undergoing mitral valve surgery for MR.

"Initiating enrollment in ACCESS-Europe is another important milestone for Evalve and the MitraClip therapy," said Ferolyn Powell, president/CEO of Evalve. "This study is designed to provide meaningful clinical and health economic information building on the important foundation of data already generated in the U.S. The early experience in Europe has been primarily the treatment of patients who are either non-surgical candidates, or higher risk surgical patients, with functional MR."

Evalve received CE-mark approval for the MitraClip system last year, and has worked with hospitals across Europe to establish training programs in support of the European roll-out. Patients have been treated in Italy, Germany, the Netherlands, Switzerland and the UK.

Percutaneous mitral repair with the MitraClip device is performed by physicians in the cath lab. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR, Evalve said.

Endeavor DES cleared in Japan

Medtronic (Minneapolis) reported the approval of its Endeavor drug-eluting coronary stent system by the Japanese Ministry of Health, Labor and Welfare, clearing the way for the launch of the product in the world's second largest market for advanced medical technology. The company said it would launch the Endeavor immediately following the authorization of reimbursement on May 1.

With the launch in Japan, the Endeavor DES is commercially available for the treatment of coronary artery disease in every major market in the world, Medtronic noted.

"The large and growing body of evidence from clinical studies and clinical practice around the world continues to demonstrate the enduring benefits of the Endeavor stent for patients with coronary artery disease," said Sean Salmon, VP of Medtronic CardioVascular and general manager of Medtronic's Coronary and Peripheral business. "We look forward to bringing these benefits to Japan very soon."

The company said that the ENDEAVOR clinical program has demonstrated that the Endeavor DES is associated with exceptionally low rates of stent thrombosis, myocardial infarction and cardiac death, as well as low rates of clinically-driven target lesion revascularization (TLR), out to as long as five years of patient follow-up. Representing various world geographies (including Japan) and patient subsets, the program has enrolled more than 10,000 subjects to date and will ultimately enroll more than 20,000 subjects in a combination of randomized controlled and single-arm trials.

ENDEAVOR Japan, a single-arm trial of Japanese subjects with a primary endpoint of TVF at nine months, reflects the consistent results of the ENDEAVOR clinical program overall and contributed to the regulatory approval of the Endeavor DES in Japan. At two years, the TVF rate in ENDEAVOR Japan was 8.7%, comparable to the same measure in other trials of the Endeavor DES, and there have been no instances of definite/probable stent thrombosis (early, late or very late), with predictably low rates of death (2.2%) and MI (2.2%).

The Endeavor DES received the CE mark in August 2005 and was approved by the FDA in February 2008.

Study reports DuraHeart benefits

Terumo Heart (Ann Arbor, Michigan) said a study reported in the European Journal of Cardio-Thoracic Surgery (EJCTS) indicates that the company's DuraHeart Left Ventricular Assist System shows sustained benefits in providing safe and reliable long-term circulatory support with an improved survival rate and an acceptable adverse event rate in advanced heart failure patients who were eligible for transplantation.

These conclusions, based on the European experience with DuraHeart, the first active magnetically levitated centrifugal left ventricular assist system, were published online in EJCTS.

The DuraHeart System is the first third-generation rotary blood pump designed for long-term patient support that incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow, while minimizing device wear and tear.

The DuraHeart System pump is implanted in a pocket created in the abdomen. When the pump is activated, the impeller position is precisely controlled by the electromagnets and sensors to keep it centered within the blood chamber.

The European study includes 68 patients who received the DuraHeart Left Ventricular Assist System between January 2004 and July 2008, including 33 treated as part of the European multi-center clinical trial (Germany, Austria, and France) and 35 treated in the post-trial period.

All patients were classified with end-stage heart failure and were on approved lists to receive donor hearts (bridge to transplant). Terumo Heart, a subsidiary of Terumo Corp. (Tokyo), sponsored the trial.

"In a patient population with advanced disease at imminent risk of death due to end-stage left ventricular failure and eligible for heart transplantation, the DuraHeart was safe and performed as intended," said Michiel Morshuis, MD, senior physician at the Clinic for Thoracic and Cardiovascular Surgery at the Heart and Diabetes Center North Rhine-Westphalia (Bad Oeynhausen, Germany). "We believe the device may have potential for long-term circulatory support not only as a bridge to transplant, but also for destination therapy."

Overall, the mean support duration for the study population ranged from 19 days to 1,148 days, with a cumulative duration of 45 years.

As of the publication date, 35 patients (51%) remained in ongoing treatment with DuraHeart, 18 patients had received heart transplants, one device was explanted and 14 patients died during support, with a median time to death of 62 days.

"Our European experience paved the way for our U.S. clinical trial, serving as a highly positive and important beginning to our plans for a broader global introduction of this much-needed technology," said Chisato Nojiri, MD, PhD, chairman and chief medical officer at Terumo Heart.

CE mark for Sorin pacemakers

Sorin Group (Milan, Italy), a company developing products for the treatment of cardiovascular diseases, reported CE-mark certification and market release of the Esprit pacemaker family in Europe. The Esprit pacemaker, the latest family in Sorin Group's pacemaker portfolio, is, according to the company, the world's smallest pacemaker, at 8cc, with no compromise on longevity.

Featuring a set of algorithms designed to help patient safety and delivering proven pacing therapies, Esprit follows the success of the Reply pacemaker launched in Europe in 2007, with a simplified user interface and SmartCheck for faster follow-ups.

Esprit includes a host of algorithms designed for patient safety: continuous lead impedance measurements to monitor the integrity of the lead, automatic adjustment of atrial and ventricular sensing, and ventricular auto-threshold to automatically adjust pacing output in case of changing thresholds.

Esprit includes Dplus, an automatic AV hysteresis algorithm designed to reduce right ventricular pacing. It also features SmartCheck, a tool designed for simplified device checks, which automates follow up tests at the click of a button.

The first Espirt pacemaker was implanted by Jonas H rnsten, MD, Cardiology Department, at Karolinska University Hospital (Stockholm, Sweden), site of the world's first pacemaker implant in 1958.

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