A Medical Device Daily

Sorin Group (Milan, Italy) reported the commercial market release and first implant of its new-generation Paradym CRT 8750 cardiac resynchronization therapy defibrillator (CRT-D).

The company said that, together with the new Situs BW 28D left ventricle pacing lead and lead delivery system, Paradym CRT forms a completely new CRT system for heart failure patients.

Paradym CRT is designed to allow more flexibility in the management of cardiac resynchronization and anti-tachyarrhythmia therapy in heart failure patients, thanks to its Brady-Tachy Overlap (BTO) feature.

Guidelines for heart failure management recommend exercise training as part of the treatment for HF patients, as it has been shown to reduce mortality and improve quality of life. With BTO, Paradym CRT is able to provide bi-ventricular resynchronization therapy at the elevated heart rates necessary to support patients' exercise.

HF patients often present slow ventricular tachyarrhythmias (slow VT) at the same elevated rates. Paradym CRT is designed to recognize and treat slow VTs without compromise to resynchronization therapy.

"The physical activity of the patient is definitely a key component to take into consideration when treating every heart failure patient," said Dr. Christian Butter, head of the cardiology department at Heart Center Brandenburg (Berlin). "Paradym CRT offers my heart failure patients the significant benefit of delivering resynchronization therapy during sustained exercise, while detecting and treating slower ventricular tachycardias without programming constraints."

Butter implanted the first Paradym CRT device in a 38-year-old woman.

Sorin noted that for heart failure patients, it is crucial that life-saving therapies are delivered only when necessary, to avoid a decrease in the patient's quality of life. It said Paradym CRT features the PARAD+ detection algorithm, "whose superior specificity in discriminating ventricular arrhythmias has been clinically proven."

Whenever a shock is needed, Paradym delivers it swiftly with an energy level of up to 37 J (42 J stored), the highest available in the market. "This will give maximum assurance to both patients and clinicians in the treatment of life-threatening arrhythmias," Sorin said.

Fred Hrkac, president of the CRM business unit at Sorin, said: "[The] Paradym CRT ... device provides patients the highest delivered energy available on the market to date in a small and long-lasting device. With Paradym CRT, patients have the opportunity to exercise, while arrhythmias at all different rates can be accurately treated."

DexCom gets CE mark for Seven

DexCom (San Diego) reported receipt of the CE mark for Seven, its seven-day continuous glucose monitoring system, enabling commercialization of the system in the European Union and the countries in Asia and Latin America that recognize the CE mark.

The Seven device is DexCom's second-generation product, designed to help people with diabetes better manage their diabetes and control their glucose levels. Diabetes afflicts an estimated 246 million people worldwide, according to the International Diabetes Federation. Diabetes is a leading cause of adult blindness, end stage kidney failure and lower limb amputations. People suffering from diabetes are also more significantly at risk for cardiovascular disease and stroke.

"We are particularly pleased with the timing of this approval in light of the excitement surrounding continuous glucose monitoring we saw at the European Association for the Study of Diabetes meeting this summer in Rome," said DexCom President/CEO Terrance Gregg. "We hope to initiate a limited launch of SEVEN in Europe before the end of 2008 and a more robust launch in 2009," he added.

Argus II study to grow in Europe

Second Sight Medical Products (Sylmar, California), a developer of retinal prostheses for the blind, reported that it will increase patient enrollment for the Argus II Retinal Implant study throughout clinical trials sites in Europe.

The three-year feasibility study is currently under way in the U.S., Europe and Mexico for people with Retinitis pigmentosa, a genetic eye disease that causes blindness.

"We are encouraged by the results we have seen in the 17 individuals that have participated in the study so far," said President/CEO Robert Greenberg, MD, PhD. "We are ... expanding our trial enrollment in order to strengthen our data, further demonstrate clinically meaningful performance and begin the process of seeking market approval."

Retinal prostheses are currently the only devices being studied to provide some sight to subjects blinded from outer retinal degenerations, such as advanced RP. Second Sight conducted its first proof-of-concept clinical study in early 2002 at Doheny Eye Institute at the University of Southern California (Los Angeles). During that study, six RP volunteers were implanted with the Argus I system and many continue to use it at home for several hours each day.

The Argus II, the latest device being studied in the clinical trial, is a second-generation retinal prosthesis that consists of a 60-electrode grid that is surgically implanted on the retina. These electrodes transmit information acquired from an external video camera that is mounted on a pair of eyeglasses worn by implanted subjects. The implant has been designed to last a lifetime, but can safely be removed if necessary.

Three European centers are participating in the feasibility study, including Hôpital Cantonal Universitaire de Genève (Geneva, Switzerland), Le Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts (Paris), and Moorfields Eye Hospital (London).

Second Sight continues to enroll subjects at these centers and may establish additional clinical trial centers in Europe.

"These first results hold a novel and quite unprecedented promise for blind subjects as well as the physicians and researchers that have the opportunity to participate in this pioneering endeavor," said Jose-Alain Sahel, MD, principal investigator and chairman of the department of ophthalmology at Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts. "We now have a strong incentive for continuing and expanding the efforts in testing this new technology."

Four ophthalmic centers in the U.S. have enrolled subjects in the study to date.