Recall for Boston Scientific’s Fetch 2 Aspiration Catheter. A Class I recall has been issued for Boston Scientific’s Fetch 2 Aspiration Catheter, due to the risk of shaft breakage during surgery. The device is used to remove small blood clots from coronary arteries. Class I recalls are the FDA’s most serious type of recall; they are used to classify recalled products that present a reasonable risk of serious injury or death.
Boston Scientific’s recall affects roughly 21,155 devices on the market. The catheters were manufactured between June 11, 2014 and February 19, 2016.
FDA Panel Discuss of the Approval of Clovis New Drug Application
In other medical device news, a U.S. Food and Drug Administration (FDA) panel will be meeting to discuss accelerated approval of Clovis’ New Drug Application for Rociletinib. The drug is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the T790M mutation, Nasdaq reports.
On April 12, the panel will vote on the following items:
- Is the observed Overall Response Rate and Duration of response for patients treated with Rociletinib better than available therapy for the proposed patient population, and is it likely to predict clinical benefit?
- Are the risks of Rociletinib, particularly with respect to QTc prolongation leading to Torsades de pointes (specific type of abnormal heart rhythm that can lead to sudden cardiac death) and other serious ventricular arrhythmias, acceptable?
- Is the benefit-risk profile favorable for the proposed patient population?