Devices

FDA Approves Abbott Absorbable Stent

FDA has approved Abbott Vascular’s Absorb GT1 bioresorbable vascular scaffold system, which releases the drug everolimus to limit the growth of scar tissue and is gradually absorbed by the body in about three years. It is the first fully absorbable stent to treat coronary artery disease.

An FDA news release says that the device is manufactured from a biodegradable polymer called poly(L-lactide), similar to materials used in other types of absorbable medical devices such as sutures. The device’s absorption by the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed.

Approval of the Absorb GT1, the agency says, was based on data from a trial of 2,008 patients that compared the rate of major adverse cardiac events between the device and a drug-eluting metallic stent. After one year, it says, the Absorb showed a major cardiac adverse event rate of 7.8%, which was clinically comparable to the 6.1% rate observed in the control group. After one year, the rate of blood clots forming within the device was 1.54% for the Absorb and 0.74% for the control.

Possible adverse events that may be associated with the procedure to insert the Absorb or with the Absorb itself include allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection, or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between the arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.

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