Product Approval Summaries

DEVICES

FDA has cleared an Alere 510(k) for its Alere i RSV test for detecting respiratory syncytial virus infection in children and adults. Results for the test are obtained in 13 minutes or less. It works by testing swab samples using Alere’s Molecular In Minutes isothermal nucleic acid amplification technology.

Bovie Medical has received FDA 510(k) clearance for its PlazXact bipolar ablator, a surgical tool designed to improve a surgeon’s precision and safety when performing arthroscopic procedures. The clearance covers the device’s cutting, vaporization and coagulation of soft tissue during arthroscopic surgical procedures, while operating with a standard saline irrigation solution. The ablator’s tip design results in lower saline temperatures, and is compatible with standard electrosurgical generators found in ambulatory surgical centers and hospital operating rooms, according to the company.

Centric Medical has received FDA 510(k) clearance for the Tarsa-Link Bunion Correction System. The device features an “opening base wedge with built-in fixation” for bunionectomies, opening base wedge osteotomies, bone fractures, fusions, or trauma treatments, according to the company. “In past opening base wedge osteotomies, a plate and screws were placed on the outside of the first metatarsal for fixation,” it says. “The Tarsa-Link Bunion System has built in fixation and sits flush within the bone, reducing the possibility of site irritation.”

FDA has approved an expanded indication for Edwards Lifesciences’ Sapien XT and Sapien 3 transcatheter heart valves for patients with aortic valve stenosis who are at intermediate risk for death or complications associated with open-heart surgery. These devices were previously approved only in patients at high or greater risk for death or complications during surgery. “This is the first time in the U.S. that a transcatheter aortic valve has been approved for use in intermediate risk patients,” an FDA news release says.

FDA has approved an Edwards Lifesciences PMA for its Intuity Elite valve system, a rapid deployment device for surgical aortic valve replacement. Built on the company’s Perimount tissue valve platform, the device is supported by data from the TRANSFORM clinical trial, which treated 839 patients in 29 centers in the U.S.

FDA has approved an ImPACT Applications de novo petition to allow the marketing of the Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric. They are the first medical devices approved that are intended to assess cognitive function after a possible concussion, according to an agency news release. The devices are not intended to diagnose concussions or determine appropriate treatments. Instead the devices are designed to test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury.

Levita Magnetics has received FDA 510(k) clearance for its Levita Magnetic Surgical System that is intended for use to magnetically retract and maneuver the gallbladder, reducing the number of surgical incisions. The device is designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site, the company says. “Previously, surgeons would need to maneuver the gallbladder through a hole (port) in the abdominal wall,” it says.

VETERINARY

FDA has approved Arata Therapeutics’ Nocita (bupivacaine liposome injectable suspension) for post-operative pain relief in dogs undergoing knee surgery.