Devices

FDA OKs Breast Reconstruction Tissue Expander

FDA has allowed for marketing AirXpanders’ AeroForm tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in treating underdeveloped breasts and soft tissue deformities. An FDA media release says that patients use a controller to independently inflate the expander, a balloon-like device that has a soft, expandable polymer shell and is gradually filled with air.

The agency says the AeroForm product differs from available saline-filled tissue expanders that are expanded by the surgeon and use a needle to pierce the skin and inject saline into the expander through a port or injection area. Since the AeroForm is filled with air, the release says, there is no need for a needle and the patient has some control over slowly expanding the device at home.

Results of a clinical trial of 99 patients using the AeroForm and 52 patient using a saline expander were reviewed by FDA. Some 96.1% of AeroForm patients and 98.8% of patients using saline expanders could have their breast tissue successfully expanded and exchanged to a breast implant, according to the release. The most common adverse events in the study were necrosis, seroma, post-operative wound infection, and procedural pain. Patients using the AeroForm did not report any serious adverse events.

FDA reviewed the data for the AeroForm system through the de novo premarket review pathway.

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