A Medical Device Daily

Terumo Heart (Ann Arbor, Michigan) said a study reported in the European Journal of Cardio-Thoracic Surgery (EJCTS) indicates that the company's DuraHeart Left Ventricular Assist System (LVAS) shows sustained benefits in providing safe and reliable long-term circulatory support with an improved survival rate and an acceptable adverse event rate in advanced heart failure patients who were eligible for transplantation.

These conclusions, based on the European experience with DuraHeart, the first active magnetically levitated centrifugal left ventricular assist system, were published online in EJCTS.

The DuraHeart System is the first third-generation rotary blood pump designed for long-term patient support that incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow, while minimizing device wear and tear.

The DuraHeart System pump is implanted in a pocket created in the abdomen. When the pump is activated, the impeller position is precisely controlled by the electromagnets and sensors to keep it centered within the blood chamber.

The European study includes 68 patients who received the DuraHeart Left Ventricular Assist System between January 2004 and July 2008, including 33 treated as part of the European multi-center clinical trial (Germany, Austria, and France) and 35 treated in the post-trial period.

All patients were classified with end-stage heart failure and were on approved lists to receive donor hearts (bridge to transplant). The trial was sponsored by Terumo Heart, a wholly owned subsidiary of Terumo Corp. (Tokyo).

"In a patient population with advanced disease at imminent risk of death due to end-stage left ventricular failure and eligible for heart transplantation, the DuraHeart was safe and performed as intended," said Michiel Morshuis, MD, senior physician at the Clinic for Thoracic and Cardiovascular Surgery at the Heart and Diabetes Center North Rhine-Westphalia (Bad Oeynhausen, Germany). "We believe the device may have potential for long-term circulatory support not only as a bridge to transplant, but also for destination therapy."

Overall, the mean support duration for the study population ranged from 19 days to 1,148 days, with a cumulative duration of 45 years.

As of the publication date, 35 patients (51%) remained in ongoing treatment with DuraHeart, 18 patients had received heart transplants, one device was explanted and 14 patients died during support, with a median time to death of 62 days.

"Our European experience paved the way for our U.S. clinical trial, serving as a highly positive and important beginning to our plans for a broader global introduction of this much-needed technology," said Chisato Nojiri, MD, PhD, chairman and chief medical officer at Terumo Heart.

The pivotal U.S. bridge to transplant trial, involving up to 40 clinical sites and 140 patients, is in process. The company also has completed trial enrollment for the device in Japan.

CE mark for new Intercept configuration

Cerus (Concord, California) reported CE-mark approval for a new configuration of its Intercept Blood System, allowing a single treatment procedure to produce two pathogen inactivated platelet units for transfusion. It said use of the new double-dose platelet set "will significantly decrease blood center cost and labor associated with production of Intercept platelets."

"Cerus is committed to offering an inactivation treatment that is not only highly effective against pathogens, but also cost-effective and user-friendly for blood centers," said President/CEO Claes Glassell. "The ... cost savings resulting from the double-dose platelet processing set will make Intercept an even more attractive choice compared to alternative blood safety technologies such as bacterial detection."

The company said the double-dose platelet processing set facilitates economical treatment and storage of double-dose platelet collections, which are estimated to account for roughly half of European apheresis platelet collections, and for the majority (60% to 100%) of apheresis collections in markets such as Germany, the UK, Ireland, Switzerland and the U.S.

The new platelet set can also be used to treat double-dose units prepared from whole blood-derived platelet pools.

Cerus also reported that the German Red Cross Blood Donor Service in the Baden-W rttemberg-Hessen region, which includes Frankfurt, has been granted authorization by the Paul Ehrlich Institute to market platelet components treated with the Intercept system. The authorization covers pooled platelets using the buffy coat method of collection.

The DRK BWH is one of the large Red Cross Blood Donor Services in Germany, collecting and processing about 25% of the blood supply in Germany.

Nanobiotix cites pre-clinical results

Emerging nanomedicine company Nanobiotix (Paris) said an independent pre-clinical study has validated the applicability of using its nanoparticles, nanoPDT, to treat glioblastoma multiforme, one of the most prevalent brain tumors.

Nanobiotix said it expects to attract corporate partners for the development of nanoPDT as the company focuses development efforts on its nanoXray technology.

Co-funded by Nanobiotix and Cancéropôle Lyon Auvergne Rhône-Alpes, the proof-of-concept preclinical study was conducted by the French National Institute for Health and Medical Research (INSERM) under principal investigator and neuro-oncologist Jérôme Honnorat, MD.

"Our nanotechnology is designed to allow for the precise destruction of cancer cells via the controlled application of an outside-the-body energy source-in this case, a laser beam," said Laurent Levy, PhD, president/CEO of Nanobiotix and co-president of the French Technology Platform on Nanotechnology.

"There is much more work to be done, but we are extremely encouraged by these pre-clinical findings, which dramatically demonstrate the therapeutic effect of nanoparticles on glioblastoma and open the possibility of a new weapon with which neuro-oncologists might fight this difficult-to-treat tumor," he said.

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