Devices

FDA Allows Morcellator Containment System Marketing

FDA is allowing the marketing of Advanced Surgical Concepts’ PneumoLiner, the first tissue containment system for use with certain laparoscopic morcellators to isolate uterine tissue that is not suspected to cause cancer. An agency statement says that although the device is an effective tissue containment system, FDA is requiring its Irish manufacturer to warn patients and healthcare providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during the procedures.

The PneumoLiner is intended to be used only in a limited patient population, the statement says, including women without uterine fibroids undergoing hysterectomy and some pre-menopausal women with fibroids who want to maintain their fertility. “A small number of women may find, after consultation with their doctor, that laparoscopic power morcellation is an appropriate therapeutic option compared to invasive surgery,” the statement says. “For these women, the device is intended to isolate and contain tissue that is considered to be non-cancerous before surgery even if the tissue is subsequently determined to be cancerous.”

Risks associated with the PneumoLiner include dissemination of morcellated tissue, injury to surrounding tissues or organs, infections, and a prolongation of the surgical procedure. The device labeling must state that its use is limited to doctors who have successfully completed the company’s validated training program.

The device labeling also is to include a Boxed Warning that is similar to that recommended for laparoscopic power morcellators, along with important Contraindications.

The agency reviewed PneumoLiner through its de novo classification process, which it describes as a regulatory pathway for some novel low- to moderate-risk medical devices that are first-of-a-kind.

FDA says that it “continues to review information on laparoscopic power morcellation, including the latest data and evolving scientific literature, and will communicate publicly on any developments that are pertinent to the agency’s thinking on this issue.”

Power morcellation has been the subject of conflicting research on its potential adverse effects and is the subject of a Government Accountability Office probe.

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