A Medical Device Daily

Cerus (Concord, California) reported that the German Red Cross in the Baden-W rttemberg-Hessen region (DRK Frankfurt) has agreed to collaborate in the development of the company's Intercept Blood System for red blood cells.

Terms of the agreement call for the DRK Frankfurt to invest both expertise and personnel in support of commercial system design, commercial system validation and activities directed toward German regulatory approval. In return, the agreement provides for DRK Frankfurt to receive royalties on potential sales of the Intercept red blood cell system in Europe.

Cerus said the collaboration provides it with access to DRK Frankfurt's scientific and operational expertise in relevant areas, committing resources from DRK Frankfurt to support the development of the commercial product and design of a system compatible with blood-processing procedures in Europe.

Under the agreement, the organizations will also work together on planning for Phase III and Phase IV clinical trials of the red blood cell system in Europe.

"Cerus is pleased that the largest region of the German Red Cross is committed to developing the Intercept red blood cell system," said President/CEO Claes Glassell. "This collaboration reflects DRK Frankfurt's recognition of the importance of pathogen inactivation and the merits of the Intercept Blood System."

He added, "The collaboration will help guide the development of the Intercept red blood cell system to meet the operational and validation requirements in large blood centers."

DRK Frankfurt is a major reference center for transfusion medicine globally, actively collaborating with transfusion medicine professionals within Germany and around the world, sharing with them data on best practices in blood banking.

The organization collects and processes 1.2 million units of red blood cells annually and has a research group that has conducted translational research in transfusion medicine for many years.

The Intercept Blood System is designed to inactivate blood-borne pathogens in donated blood components intended for transfusion. Cerus currently markets the system for both platelets and plasma in Europe and the Middle East. The company also is pursuing regulatory approvals in the U.S. and other countries. The red blood cell system is in clinical development.

Six-month data show gains with CardioFit

BioControl Medical (Yehud, Israel) reported the publication of six-month data for eight of the more than 30 patients who participated in the European pilot study of its CardioFit device for congestive heart failure (CHF).

All eight patients were enrolled at the Fondazione IRCCS Policlinico San Matteo and the University of Pavia in Italy. The results are published in the September issue of the European Journal of Heart Failure.

The article was authored by the study's principal investigator, Peter Schwartz, MD, along with his research associates. The article, titled "Long-Term Vagal Stimulatyion in Patients with Advanced Heart Failure-First Experience in Man," describes the use of CardioFit's implantable vagal stimulation system in a pilot study designed to assess, for the first time ever, the feasibility and safety and possible efficacy of chronic vagal stimulation in CHF patients.

"A significant 40% improvement was observed in the commonly used Minnesota Living with Heart Failure Quality of Life questionnaire and in left ventricular end-systolic volume," said Schwartz. A favorable trend toward reduction was also observed in end-diastolic volume [and] despite their difficult baseline condition, the patients' NYHA functional class improved significantly."

The eight patients, all with advanced CHF, had a mean age of 54 years. Two to four weeks after implantation of CardioFit, vagal stimulation was initiated and intensity increased according to a prospective protocol. "It is our opinion as investigators that the CardioFit's novel approach to the treatment of patients with heart failure is feasible, and appears safe and tolerable," Schwartz said. "The preliminary efficacy results support the commencement of a controlled multi-center study in a larger population to confirm the seeming efficacy of the system."

"[Our] implantable neuromodulation technology has a wide range of applications," said Dr. Ehud Cohen, CEO of BioControl Medical. "To date, it is being applied to develop therapeutic devices in urology and for the treatment of congestive heart failure. In parallel with the development of these products, the company is also investigating applications for other indications."

He added, "The main focus of the company today is the initiation of an international, multi-center, pivotal study of the CardioFit system, which we believe will likely make a significant impact on existing clinical protocols once approved in the U.S. and Europe."

The company said details pertaining to the six-month data on the first 20 patients in the pilot study will be addressed in a presentation at the American Heart Association's annual scientific sessions in New Orleans in November.

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