Product Approval Summaries

DEVICES

Becton Dickinson has received FDA approval for its  BD Totalys MultiProcessor and BD Totalys SlidePrep instruments for use in cervical cancer screening, as well as providing ancillary testing aliquot capability.

FDA has approved Boston Scientific’s Blazer Open-Irrigated radiofrequency ablation catheter to treat Type I atrial flutter, an abnormal rhythm of the upper chambers of the heart. The company says it is designed for use in ablation procedures to restore a normal heart rhythm for patients in atrial flutter.

Cepheid has received FDA 510(k) clearance for the Xpert Carba-R, an in vitro diagnostic test for identifying distinct families of carbapenem resistance genes that together represent the most common carbapenemases identified globally, including KPC, NDM, VIM, OXA-48 and IMP.

FDA has cleared a Cochlear Ltd. 510(k) for the Cochlear Baha 5 SuperPower Sound Processor for use in children and adults with high degrees of mixed hearing loss. The device is designed to make difficult listening situations easier, according to the company, which describes it as the “first and only super power bone conduction solution with smart, direct-to-device wireless technology for patients with significant hearing loss.” The device combines the company’s bone conduction technology with its Nucleus cochlear implant. It features a behind-the-ear sound processor with a fitting range up to 65 dB SNHL. “

FDA has cleared a Life Spine 510(k) for the Prolift Expandable Interbody System for use in spinal disorder surgeries. The all-titanium device is designed to restore disc height, in-situ, during posterior lumbar interbody fusion, transforaminal lumbar interbody fusion and oblique surgical approaches. The company says it allows for “simplified, contracted insertion with minimal anatomical disruption and retraction. Once implanted, it can expand cephalad to caudal to accommodate disc height ranges from 8mm to 16mm for varying patient anatomy.”

FDA has approved a Sensimed de novo marketing application for the Triggerfish, a single-use contact lens that may help practitioners identify the best time of day to measure a patient’s intraocular pressure (IOP).

Visunex Medical Systems has received FDA 510(k) clearance for its Visunex Medical Systems PanoCam Pro Wide-field Imaging System for imaging newborn infants for vision disorders. The wireless device can help detect external, anterior, and posterior segment vision disorders that may have long-term effects, according to the company. The test is performed before a newborn is discharged to home.

HUMAN DRUGS

FDA has given expanded approval to Pfizer’s Xalkori (crizotinib) to treat people with metastatic non-small cell lung cancer (NSCLC) whose tumors have an ROS-1 gene alteration. This gene alteration is present in about 1% of patients with NSCLC. “The overall patient and disease characteristics of NSCLC with ROS-1 gene alterations appear similar to NSCLC with anaplastic lymphoma kinase (ALK) gene alterations, for which crizotinib use was previously approved” in 2011, an agency release says. Xalkori works by blocking the activity of the ROS-1 protein in tumors that have ROS-1 gene alterations, it says, adding that this effect “may prevent NSCLC from growing and spreading.”

FDA has approved a Teva Pharmaceuticals ANDA for a generic copy of Pfizer’s Viagra (sildenafil citrate) tablets, 25 mg, 50 mg, 100 mg, indicated for treating erectile dysfunction. Teva and Pfizer settled patent litigation in 2013, with Teva agreeing not to market its product until 12/2017. Once it hits the market, Teva must pay Pfizer patent royalties through 4/2020 under the agreement.