Thoratec: more than 200 in HeartMate trial

Thoratec (Pleasanton, California) reported that more than 200 total patients have been enrolled in the worldwide Phase II pivotal trial of its HeartMate II LVAS (left ventricular assist system), the company's next-generation ventricular assist device.

The company said it had received FDA approval to expand the number of centers participating in the bridge-to-transplantation arm of the Phase II trial to 40 from the current 25. It said it expects the first of these centers to have institutional review board approval during the current quarter.

As of Jan. 6, 154 patients have been enrolled in just the phase II portion of the U.S. trial. This includes 79 in the BTT arm and 75 in the Destination Therapy arm of Phase II.

Inovise receives ISO certification

Inovise Medical (Portland, Oregon) reported the company reached a major milestone when it received certification to ISO 13485:2003, an international standard designed to ensure high quality medical products and services are developed and manufactured for consumers worldwide.

“ISO certification confirms the company's quality management systems are in place to provide the global healthcare community with the highest quality medical products and services,“ said Steve Hesler, director of quality and regulatory.

The company's flagship technology, Audicor, is an easy-to-use, non-invasive diagnostic technology helping medical professionals quickly rule-in cardiac dysfunction including acute heart failure, acute coronary syndrome and other high-risk cardiac conditions.

Clarient relocates laboratory

Clarient (Aliso Viejo, California), a technology and services resource for pathologists, oncologists and the pharmaceutical industry, reported moving its Diagnostics Services laboratory to a new, expanded facility in Aliso Viejo. The lab has been awarded accreditation by the Commission on Laboratory Accreditation of the College of American Pathologists, based on the results of an on-site inspection.

Clarient said the move was motivated in part by capacity constraints at its former facility.

Ronald Andrews Jr., president and CEO, said the new facility “will allow us to use our current resources more efficiently, provide increased capacity to achieve the growth expected over the coming years and add new technologies for advanced cancer assessment as they become available.“

Clarient provides technologies, services and support for the characterization, assessment and treatment of cancer. It is majority-owned subsidiary of Safeguard Scientifics (Wayne, Pennsylvania).

No Comments