A Medical Device Daily

CoreValve (Paris/Irvine, California) said it has completed minimal enrollment in a clinical trial involving its second-generation CoreValve Percutaneous ReValving system.

Fifty-one patients at seven investigative sites in Europe and North America have now successfully undergone percutaneous aortic valve replacement (PAVR) with the second-generation, 21 Fr ReValving system to treat either aortic stenosis, aortic regurgitation or failed-tissue-valve-prosthesis conditions. Each of the patients was at high risk for open-heart surgery.

CoreValve said it expects to use the results of this trial as part of a future CE-mark submission seeking approval to market the ReValving system in the European Union.

“We have developed a breakthrough system for replacing an aortic valve via a peripheral, intravascular, percutaneous approach on a beating heart,” said Jacques Seguin, MD, PhD, chairman, CEO and founder of CoreValve.

“The result is that 100% of the patients discharged from various hospitals involved in our second-generation clinical trial continue to show improved cardiac function with no complications, while enjoying a dramatically enhanced quality-of-life at follow-up now out to 17 months in some cases,” he said. “We are confident that the results of this study, when completed, will be part of the strong foundation for a CE-mark submission.”

Rob Michiels, president and COO, said the trial has “dramatically underscored the significant benefits of our second-generation . . . system compared to the first-generation, system. The smaller catheter greatly improves the ease of the ReValving procedure, and our investigators are now routinely accessing, delivering and placing our porcine pericardial-tissue bioprosthesis in less than 15 minutes.”

He said the company is “moving immediately toward another clinical trial using our third-generation system, whose delivery catheter has been downsized to 18 Fr. This further reduction in size is particularly important to the interventional cardiologist when accessing a diseased aortic valve via calcified and tortuous vessels.”

Michiels said CoreValve “fully expects” the 18 Fr system to also make alternative access through the subclavian arteries feasible.

Cepheid's Smart CMV Assay okayed

Cepheid (Sunnyvale, California) reported the European release of the Smart CMV (cytomegalovirus) Assay for clinical diagnostic use on the SmartCycler System. The CMV assay was released under the European Directive on In Vitro Diagnostic Medical Devices.

Smart CMV is intended for rapid detection and quantitation of CMV viral load. CMV is a member of the herpes virus family, which includes the herpes simplex viruses and the viruses that cause chicken pox (varicella-zoster virus) and infectious mononucleosis (Epstein-Barr virus).

Most CMV infections are asymptomatic and often lead to undetected, latent infection and re-infection. Among immuno-compromised patients such as organ transplant recipients, AIDS and cancer patients, CMV infection is a significant cause of disease and mortality.

Cepheid said periodic monitoring of CMV viral load in consecutive clinical samples is used to identify high-risk patients and to monitor their response to CMV therapy. “Because of their specificity and sensitivity, real-time polymerase chain reaction diagnostics like Smart CMV are an important tool in the effective clinical management of CMV patients,” the company said.

“Cytomegalovirus is an important pathogen in immunosuppressed patients, including organ transplant recipients and AIDS patients. The clinical utility of quantitative CMV DNA tests in managing these patient groups has been well documented,” said Mario Poljak, MD, PhD, head of the Laboratory for Molecular Microbiology and of the Slovenian AIDS Reference Center at the Medical Faculty of Ljubljana in Slovenia.

“Smart CMV is the sixth in a planned menu of CE IVD mark products launching into the European market this year, and the third product in our expanding portfolio for use in the management of immuno-compromised patients,” said Cepheid CEO John Bishop. “[Our] scaleable SmartCycler and GeneXpert technologies are making it easier and cost effective for institutions of any size to reap the benefits of molecular diagnostics.”

The SmartCycler system is a real-time PCR testing platform for hospitals, university research labs and government agencies. By automating the amplification and detection process, the system can deliver highly accurate and consistent test results from prepared biological samples in about 30 to 40 minutes, Cepheid said.

With up to 96 independently programmable reaction sites, the SmartCycler System can simultaneously run different tests with different protocols and at different times.

New hydrogel breast implant coming

Heritage Worldwide (LaSyeyne-Sur-Mer, France) reported that it believes it will be able to introduce this year a new type of breast implant that is pre-filled with a proprietary formulation of hydrogel, of which the largest component is distilled water.

The pre-filled hydrogel implants would be manufactured in the company's ISO-certified cleanroom, with their use expected to be permitted first in the European Community.

Founder and Chairman Jean-Claude Mas said, “Our R&D has been successful in working with our form of hydrogel to attain the same feel inside the body as silicone gel implants, but of course hydrogel does not have the same characteristics as silicone gel because it is largely compounded of water and some naturally occurring sugars.”

He added: “Although we cannot predict when we will be awarded CE-mark clearance, we believe it will be later this year, and, after clearance, we would be able to start shipping the hydrogel implants very quickly.”

Mas said the company believes that the hydrogel implants will be easily accepted by surgeons and patients, who currently prefer silicone gel-filled implants outside the U.S., and saline-filled implants in the U.S. “Hydrogel offers an elegant solution with the advantages of a gel, and the simplicity of being a water-based substance,” he said.

Heritage sold an earlier generation pre-filled hydrogel implant beginning in 1992, but that product was discontinued in 2001. The new hydrogel implant has been completely redesigned and retextured.

The company's products are sold in 65 countries, primarily in Europe, the Middle East, Latin America and Australia.

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