Product Approval Summaries

DEVICES

FDA has approved an Abiomed PMA for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of ongoing cardiogenic shock. “In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart,” the company says. Previously, the devices were approved for high risk percutaneous coronary intervention (PCI), or protected PCI. The Impella devices are intended for short-term use (less than four days for the Impella 2.5 and Impella CP and less than six days for the Impella 5.0 and Impella LD) and indicated for treating ongoing cardiogenic shock that occurs immediately (less than 48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump, according to the company.

Biotronik has received FDA approval for a PMA for its BioMonitor 2, a subcutaneously insertable cardiac remote monitor with ProMRI technology. The device is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. It can also be used to monitor atrial events in patients who have undergone ablation procedures, according to the company.

FDA has cleared an EOS Imaging 510(k) for spineEOS, an online 3D planning software for spine surgery based on the company’s EOS stereo-radiographic 2D/3D imaging technology. The planning software is intended for adults suffering from degenerative or deformative spine conditions, as well as for pediatric patients with adolescent idiopathic scoliosis. It allows a surgeon to “create a treatment plan to achieve optimal sagittal alignment from pelvic and vertebral 3D data obtained in the functional standing position from an EOS exam,” the company says. “The planned surgery and virtual post-correction 3D anatomy can be used to precisely plan for the 3D shape and length of the spinal implants.”

FDA has approved an Epigenomics PMA for its Epi proColon, the first FDA-approved blood-based colorectal cancer screening test. The device is indicated for colorectal cancer screening in average-risk patients who choose not to undergo colorectal cancer screening by guideline-recommended methods such as colonoscopy and stool-based fecal immunochemical tests.

Redwood City, CA-based Nevro Corp. has received FDA approval for surgical leads that are specifically designed for use with the Senza Spinal Cord Stimulation (SCS) System delivering HF10 therapy for chronic leg and back pain. The company says its HF10 therapy delivers electrical pulses to the spinal cord via small electrodes on leads placed near the spinal cord and connected to a compact battery-powered generator implanted under the skin. It adds that HF10 is the only SCS therapy indicated to provide pain relief without paresthesia ( a tingling or buzzing that is the basis of traditional SCS).

FDA has cleared a Trividia Health 510(k) for its True Metrix Go Self-Monitoring blood glucose system. The device includes a meter that twists on to a vial of True Metrix test strips that consolidate, with a mini lancer, into a compact, all-in-one blood glucose system that can be placed in a shirt pocket, purse or bag, according to the company. It also features Triple Sense Technology that is designed to detect, analyze and correct for environmental and physiological variability, including hematocrit and temperature.

HUMAN DRUGS

FDA has approved an AbbVie NDA for Venclexta (venetoclax) and its use in treating patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a least one prior therapy. An FDA release says the drug is the first agency-approved treatment that targets the B-cell lymphoma 2 (BCL-2) protein, which supports cancer cell growth and is overexpressed in many patients with CLL. A companion diagnostic, Roche’s Vysis CLL FISH probe kit, was also approved to help select appropriate patients for treatment.

Boehringer Ingelheim has received FDA approval of a supplemental NDA for Gilotrif (afatinib) tablets for treating patients with advanced squamous cell carcinoma of the lung whose disease has progressed after treatment with platinum-based chemotherapy.