Devices

FDA Authorizes Interscope EndoRotor System

FDA has authorized the marketing of Interscope’s EndoRotor system to resect and remove necrotic tissue for patients with walled-off pancreatic necrosis. An agency statement says the system includes a power console, foot control, specimen trap, and single-use catheter, and is used in a direct endoscopic necrosectomy.

The system’s safety and effectiveness were assessed in a trial with 30 subjects (23 in the U.S.) with walled-off pancreatic necrosis who were indicated to undergo a direct endoscopic necrosectomy, FDA says. The device’s effectiveness was studied by how well it cleared necrotic tissue from the subject’s pancreas. For subjects undergoing procedures with the EndoRotor system, the statement says, there was an average of 85% reduction in the amount of necrotic tissue, with half of the subjects having a 98.5% clearance of their necrotic tissue.

In the trial, FDA says, three subjects experienced procedure-related serious adverse events. Two had gastrointestinal bleeding and one experienced pneumoperitoneum and later died from sepsis and multi-organ system failure caused by massive collections of infected pancreatic necrosis.

The device was reviewed through the De Novo pathway for some novel low- to moderate-risk devices.

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