A Medical Device Daily

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.

Spinal implant trial set for Artelon

Artimplant (Vasta Frolunda, Sweden) reported taking its first step toward treatment of spinal disorders with its biomaterial Artelon biomaterial. An Artelon implant will be used for investigational treatment of osteoarthritis of the lumbar facet joints, with the investigator, Schulthess Clinic Spine Center (Zurich, Switzerland), planning to start enrolling patients during 2Q09.

Schulthess Clinic Spine Center has received a letter of confirmation from Swissmedic to commence the clinical investigation of the Artelon implant. The aim of this pilot clinical investigation is to evaluate the feasibility of treating osteoarthritis of the lumbar facet joints of the spine with such an implant.

Artimplant said the pain relief provided by this treatment will be examined and the patients will be followed up for two years. It said, "The study will form the basis for documenting the safety and ease of use of the Artelon implant in spine applications and establishing the post-surgical instructions."

Artimplant has more than nine years of clinical experience of Artelon in the treatment of osteoarthritis in small joints in the hand, wrist and foot. It said applying the Artelon resurfacing concept to the facet joint is "a logical step for Artimplant and is in line with the trend in spine surgery toward motion preservation."

The company said, "Implanting the Artelon device is less invasive than most other spine procedures and can be performed through the patient's back. Thereby the patient can resume normal activities after a short recovery period."

Blood info system licensed in Germany

Global Med Technologies (Denver), an international healthcare information technology company, said that GLI, the German division of the company's Inlog subsidiary, has licensed its EdgeBlood blood information management system and EdgeLab laboratory information system to the University of Saarland Clinic Blood Center (Homburg, Germany).

The University of Saarland Clinic Blood Center collects 30,000 whole blood donations a year. EdgeBlood and EdgeLab will be deployed on 25 workstations in the blood center and laboratory, and up to 50 remote users will access the web result server EdgeNet. Five analyzers will be connected to EdgeLab, Inlog's LIS.

"After detailed market research, the University Medical Center of Saarland has decided to install the LIS EdgeBlood/EdgeLab," said Hermann Eichler, MD, of the Institute of Clinical Hemostaseology and Transfusion Medicine at Homburg/University Medical Center of Saarland. "This decision was made because, among other reasons, the system can completely control the management of all essential services in transfusion medicine. Moreover, the software is already in use in the National German Red Cross Blood Donation Services."

EdgeBlood is used to process more than half the blood drawn in Germany, as well as processing significant parts of the Austrian and Swiss blood supplies. It also is used in Greece as well as five African countries.

EdgeBlood, known as CTS Serveur in the French market, manages all blood that is drawn, tested, produced and labeled in France by the Etablissement Francais du Sang, the French Blood Establishment.

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