Clinicians soon will have a new option to control certain types of bleeding in the gastrointestinal (GI) tract, thanks to the FDA giving its nod to Cook Medical Inc.'s endoscopic hemostat.

WASHINGTON – CDRH Director Jeffrey Shuren encouraged the increased use of real-world evidence (RWE) and put an emphasis on the FDA's total product life cycle (TPLC) reorganization during his presentation last week at the Food and Drug Law Institute's annual conference. At the same time, he provided an overview of CDRH's current activities, including implementation of 21st Century Cures, as well as the center's vision for the future.

Following an FDA supplemental approval, a new disposable spinal instrument kit will be available to outpatient and ambulatory surgery centers. The approval marks the first time the agency has signed off on such a kit for a class III spinal device, according to New York-based Paradigm Spine LLC. The kit will complement Paradigm Spine's Coflex interlaminar stabilization product, which is indicated for use in one or two level lumbar stenosis in skeletally mature patients. These patients have at least moderate impairment in function and have undergone six months or more of nonoperative treatment.

The FDA has approved Dublin-based Medtronic plc's deep brain stimulation (DBS) therapy as adjunctive treatment for reducing the frequency of partial-onset seizures. The therapy is for use in individuals 18 years of age or older who are resistant to three or more antiepileptic medications. Medtronic plans to launch the therapy in the U.S. this year, said Mike Daly, vice president and general manager of the company's brain modulation business.

The FDA has approved Medtronic plc's Infuse bone graft for new spine surgery indications, marking the second expanded indication for the product in two years.

Mitraclip, an alternative to mitral valve regurgitation surgery from Abbott Park, Ill.-based Abbott Laboratories, demonstrated favorable 30-day and one-year outcomes, according to data from a postapproval study evaluating the safety and efficacy of the device. According to the results, 86.8 percent of patients had post-procedural mitral regurgitation of ≤2+ at one year.

A liquid biopsy assay that incorporates multiple companion diagnostics has gotten a boost from the FDA. Cambridge, Mass.-based Foundation Medicine Inc. reported that the agency had granted a breakthrough device designation for an expanded version of its FoundationACT (Assay for Circulating Tumor DNA) assay, which would include more than 70 genes and genomic biomarkers for microsatellite instability and blood tumor mutational burden.