A Medical Device Daily

Medtronic (Minneapolis) reported that an appeals court in Germany has found that its CoreValve transcatheter aortic valve system does not infringe Edwards Lifesciences' (Irvine, California) Germany Andersen patent, which is set to expire in May 2011.

The appellate court's decision upholds a lower court's ruling and enables uninterrupted access to the heart valve in Germany, Medtronic noted. The company said that court proceedings involving the UK counterpart to the German Andersen patent are scheduled to resume May 14 in London with an appeal from the trial court. The U.S. District Court of Delaware is scheduled to begin a trial March 23 involving related U.S. patents.

"We are gratified but not surprised by today's ruling," said Scott Ward, president of the CardioVascular business and a senior VP at Medtronic. "We look forward to similar outcomes in the UK and the United States."

As in Germany, the UK trial court found in January 2009 that CoreValve devices do not infringe the Edwards' UK Andersen patent, Medtronic said.

Medtronic contends that CoreValve devices do not use the technology disclosed and claimed in the Andersen patents. As a result, the company maintains that it does not need a license to those patents in order to sell CoreValve devices.

The CoreValve transcatheter aortic valve system is designed to enable replacement of a diseased aortic valve without open-heart surgery and without surgical removal of the diseased valve.

Edwards said the ruling has no effect on sales of the Edwards Sapien transcatheter heart valve technology.

"While we are disappointed by this decision on infringement, we will continue to rigorously enforce our leading intellectual property portfolio in this field. We look forward to the trial on the U.S. Andersen patents beginning next month," said Larry Wood, Edwards' corporate VP of transcatheter valve replacement.

Last month, the Federal Patent Court in Munich, Germany, upheld the validity of Edwards' patent for transcatheter valve technology and Edwards succeeded in having CoreValve's invalidity claims dismissed on all grounds, Edwards noted.

NovaShunt initiates PIONEER study of AFS

NovaShunt (Zug, Switzerland) reported the initiation of its pivotal multi-center clinical study, PIONEER, a perspective, open label, non-randomized study to investigate the safety and performance of the Automated Fluid Shunt (AFS) in patients with ascites and diuretic resistance.

The study is designed to evaluate the safety and performance of the AFS system in replacing the need for paracentesis, the standard therapy for patients with refractory ascites. Secondary parameters in the study are concomitant reduction in the need for medication, healthcare costs, and patients' quality of life, the company said. Data from the PIONEER study will be submitted to the Notified body to obtain CE marking, which will allow NovaShunt to enter the European market. The principal investigator of the study is Jose Such, MD, head of hepatology at the University General Hospital (Alicante, Spain), and will be initialized in five university hospitals in Europe specialized in managing patients with refractory ascites (located in Alicante, Barcelona, Frankfurt, Regensburg and London).

"We are very excited to begin the clinical evaluation of a novel technology for the treatment of patients with refractory ascites," Such said. "As there are many patients in our clinic suffering from decompensated cirrhosis and the presence of ascites, the AFS system could be of great benefit for these people."

The AFS system is an implantable, battery powered pump designed to automatically and continuously removes excess fluid – known as ascites – that builds up in the abdominal cavity in patients with liver disease and other conditions.

"This is a milestone in our company history," said Noel Johnson, CEO and co-founder of NovaShunt. "And we strongly believe that this trial will both provide important clinical information and also demonstrate the benefit of continuous removal of ascites by the AFS system in patients suffering from refractory ascites due to liver disease and other conditions."

Companies win wound dressing patent ruling

EuroMed (Orangeburg, New York) and Jentec (Lawndale, California) reported an important victory affirming the validity of a key patent, European patent number 1020198 (U.S. corresponding patent number 6878385) for Wrinkle-Resistant Wound dressings.

In a ruling issued by the European Patent Office in Berlin, both of the grounds for opposition raised by the plaintiff, a prominent woundcare manufacturer (i.e., extension of subject-matter, lack of inventive step' or sufficient originality) weren't adequate cause to challenge the patent.

EuroMed is a designer and manufacturer of wound care management products, and one of a select few custom hydrocolloid manufacturers providing comprehensive private labeling services.