A Medical Device Daily

CoreValve (Irvine, California/Paris) said last week that it has initiated the feasibility phase of a clinical trial using its third-generation 18 Fr ReValving System. The “Generation-3” trial, which has commenced ahead of schedule, is expected to enroll up to 100 patients at 12 sites in Europe and Canada.

The first procedure was performed in the cath lab at the Heart Center (Siegburg, Germany).

The company's third-generation system, consisting of an 18 Fr-sized delivery catheter, was used to percutaneously implant CoreValve's porcine pericardial-tissue bioprosthesis over the severely calcified aortic heart valve of a 91-year-old female patient, who was discharged from the hospital's ICU on the morning after her ReValving procedure.

CoreValve said that to date, all of the 44 ReValving patients who have been discharged from the hospital “continue to demonstrate improved cardiac function, zero long-term complications and dramatically enhanced quality of life at follow-up out to 17 months,” with a mean follow-up of 9.5 months.

It said that, left untreated, “up to 25% of these high-risk and inoperable patients would have faced certain death within 12 months.” Jacques S guin, MD, PhD, chairman, CEO and founder of CoreValve, said the ReValving System has “extraordinary possibilities for interventionally treating the thousands of patients who have defective aortic heart valves but who are contraindicated for open-heart surgery.”

Noting that the company's first generation of percutaneous aortic valve replacement catheters was 25 Fr, “which is a very sizeable catheter by interventional standards,” he cited the reduction in size to 18 Fr, terming that “a rather extraordinary technical achievement in the less than two years since our 'first-in-man' procedure.”

The reduction in size offers “significant procedural benefits for the interventional cardiologist and his patient,” S guin said.

Rob Michiels, president and chief operating officer, said, “This rapid technological progress is the result of a strategy that focused on a new design for a bioprosthesis specifically for percutaneous application. We believe we are on schedule to secure a CE mark and first-to-market position for our ReValving System in Europe next year.”

Xenomics in TB test collaboration

Xenomics (New York) said that a clinical development program using its DNA-based diagnostic technology was ranked by the European Commission as among the best technology development programs in the European Union.

SpaXen, Xenomics' collaborative venture with Italy's National Institute for Infectious Diseases (INMI), leads an international consortium focusing on the development of a diagnostic test for tuberculosis using Xenomics' DNA technology.

The consortium consists of researchers with the National Institute for Infectious Diseases, the University College of London, the University of Zambia School of Medicine, the University of Munich, the Mbeya Medical Research Program and the Foundation for Innovative New Diagnostics.

The consortium is in the final contract negotiation phase in preparation for EUR 2 million in funding by the European Commission for the development of the test.

“Commercially successful testing methods for detecting and monitoring tuberculosis infections have not appreciably changed in 50 years,” said L. David Tomei, PhD, Xenomics' CEO and co-founder. “[Our] non-invasive, urine-based DNA diagnostic technology will foster fundamental improvements in safety, accuracy and functionality of diagnostic testing for tuberculosis.”

The current definitive diagnostic test for tuberculosis is a culture which takes up to three months to complete. Individuals with tuberculosis often are unaware of their condition during that period and are highly infectious.

ISO audit okays Synergetics plant

Synergetics USA (O'Fallon, Missouri) said it has received notice from its European Notified Body that its electronics manufacturing plant located in Oaks, Pennsylvania, completed an audit to ISO standard 13485-2003. Products manufactured in the Pennsylvania facility now qualify for the CE mark. Synergetics can directly distribute its Malis branded products into European Union countries and other countries that require CE-mark registration.

Gregg Scheller, president and CEO of Synergetics, cited the company's progress in establishing an international dealer network, saying, “Within seven months, our international sales team has managed to attract some of the best international dealers for neurosurgery . . . on the strength of the Malis and Omni brands.”

Following the September 2005 merger of Synergetics and Valley Forge Scientific (Oaks, Pennsylvania), the company has pursued direct distribution of its products worldwide. In April, the company reported that it had successfully completed all product labeling and regulatory requirements necessary to ship its Omni product into most international markets.

To date, the company has secured distribution partners in 41 countries, including most major international markets. With this CE mark approval, its full line of electrosurgical generators, an accompanying irrigation module, associated disposables and instruments are available to be marketed internationally.

No Comments