A Medical Device Daily

Boston Scientific (Natick, Massachusetts) reported receipt of the CE mark and the first human implants of the company's Endotak Reliance 4-Site defibrillation lead system. Defibrillation leads connect an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart and, when needed, deliver life-saving therapy.

The Endotak Reliance 4-Site lead system is designed to simplify the implant procedure by combining three terminals into one integrated connector, reducing the required implant area within the body. This system, combined with the new Teligen ICD and Cognis CRT-D, is designed to comply with the forthcoming international connector standard.

The new standard will permit product compatibility across manufacturers. The Company is working with physicians to launch the system in several phases with a focus on monitoring clinical performance through robust post-market analysis enhanced by the Latitude Patient Management system.

"We are pleased to announce CE mark and the first human implants of the Endotak Reliance 4-Site lead system," said Fred Colen, president, Boston Scientific Cardiac Rhythm Management. "This new system represents the next advance for the Endotak Reliance lead family, which has demonstrated reliability in more than 350,000 implants worldwide."

Boston Sci said this technology "allows the world's smallest, thinnest high-energy ICDs and CRT-Ds to become even smaller." It said the connector reduces the volume of Teligen and Cognis to 32 cc and 30 cc, respectively, while maintaining a thickness of less than 10 mm.

Some models of the Endotak Reliance 4-Site product line feature a proprietary Gore covering designed to prevent tissue ingrowth into the defibrillation coils, without compromising the electrical performance of the lead. The Endotak Reliance G model is the only defibrillation lead on the market to address tissue ingrowth using this approach. Preventing tissue ingrowth assists physicians with the long-term management of device patients. Although rare, lead removal is sometimes necessary. Studies have shown that the proprietary covering helps physicians perform this procedure more easily and effectively.

The implants were performed under the leadership of Oliver Przibille, MD, Cardioangiolisches Centrum Bethanien (Frankfurt, Germany); Hans-Joachim Trappe, MD, Marienhospital Herne Klinikum der Ruhr-Universitat Bochum (Herne, Germany); Johannes Heintze, MD, Herz und Diabeteszentrum Nordrhein-Westfalen Bad Oeynhausen (Bad Oeynhausen, Germany); and Lieselot van Erven, MD, Leiden University Medical Center (Leiden, the Netherlands).

CE mark for new occluders

Occlutech (Jena, Germany), which terms itself "the leading European developer of septum occluders," said it has obtained CE-mark approval for its new-generation ASD and PFO occluders, the Figulla Flex.

The Figulla Flex ASD and PFO occluders encompass what the company said is "a new innovative delivery system, making the use of a threaded hub unnecessary. The implantation of the occluder is facilitated by the ability of the delivery system to allow a 45 degree angle before release."

The Occlutech Figulla Flex will be exhibited and demonstrated at the EuroPCR vascular intervention meeting in Barcelona from May 19-22.

Occlusion devices are used to treat structural heart disease, including structural heart defects and abnormalities such as atrial septal defects, (ASD) and patent foramen ovale (PFO, an undesired channel between the heart's two atria, present in up to 25% of the population), in minimally invasive, non-surgical procedures.

m.pulse gets CE mark

Cardiola (Winterthur, Switzerland) said it has received CE-mark recertification to market its m.pulse system for at-home use to treat chronic heart failure (CHF), the most frequent cause of hospitalization in persons 65 and older.

Current treatments for CHF, including drugs, implantable defibrillators/pumps and heart transplantation, have significant risks and side effects. Cardiola's m.pulse system, based on Muscular Counter Pulsation technology, has been recertified in Europe for treating CHF as a nonsurgical, at-home therapy.

Battery-powered m.pulse, the size of a cell phone that the patient attaches to his belt for about 45 minutes per treatment, is synchronized to his cardiac cycle to stimulate the muscles of the calves and thighs to make them contract counter to the heart's beating. "This well-established counterpulsation action results in increased blood flow to the heart muscle while decreasing the heart's workload," Cardiola said.

Counterpulsation previously was available only in a clinical setting, but with m.pulse now is available at home.

The company also reported the appointment of Walter Lange as COO and Josef Jungert as vice president of sales. It also has hired four direct sales representatives.

Prior to joining Cardiola, Lange was head of product management at Egro Coffee Systems and Siemens Building Technologies.

Jungert is an industry veteran with more than 30 years of experience in sales and marketing of medical devices. He was an advisor to Cardiola prior to joining the company as VP of sales. Jungert began his career in sales management positions at 3M and GE Medical Systems. Other experience included Wesley Jessen and PLC Medical Systems. Prior to joining Cardiola, he was director of sales aesthetics for WaveLight.