Devices

Advisors Support TransMedics’ OCS Liver System

Members of the FDA Gastroenterology and Urology Devices Panel voted 12-1-1 on 7/14 that the benefits of the TransMedics OCS (organ care system) liver preservation system outweigh its risks. Votes on the device’s safety and effectiveness were unanimously supportive, MedTechDive reports. The online report says the only downsides for the company were votes against the inclusion of additional claims.

An agency briefing document circulated before the panel meeting suggested the company would have a difficult time addressing concerns with its filing. But the panel members were broadly supportive of the technology and the support evidence the company offered.

Financial analysts said they expect FDA to approve the device for use in organs donated after brainstem and circulatory death.

MedTechDive says FDA raised questions about the adequacy of the data in livers donated after circulatory death (DCD) but the financial analysts expect the labeling to include such organs.

Panelists downplayed other issues raised by FDA, the report says, but did vote broadly against the inclusion of additional claims on the ability to determine the suitability of livers for transplantation, increased use of DCD livers, and reductions in ischemic biliary complications.

It is anticipated that FDA will require TransMedics to run a post-approval study and continue to follow patients enrolled in the clinical trial.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome