Drugs

CorMatrix Begins Study of New Heart Valve

CorMatrix Cardiovascular has begun a feasibility study involving its tissue-engineered regenerative CorMatrix ECM Tricuspid Valve. The study at eight sites in the U.S. is intended to demonstrate proof of principle and initial clinical safety of the valve for the surgical management of tricuspid valve disease not amenable to annuloplasty or repair, including tricuspid valve disease secondary to congenital heart disease in pediatric and adult patients with tricuspid endocarditis.

The unstented valve is designed to function immediately after implantation as a competent heart valve and to perform efficiently at lower transvalvular pressure gradients as experienced by the normal tricuspid valve, according to the company. Its bioscaffold characteristics “enable native cells to infiltrate and remodel over time into a fully functioning tricuspid valve,” it says. “The implanted, remodeled valve is comprised of the patient’s own tissue and leaves behind no ‘foreign body’ as is the case with all mechanical or prosthetic valve designs,” it says. In addition, the valve does not require long-term anticoagulation therapy associated with mechanical valve implants.

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

Read more

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