Product Approval Summaries
DEVICES
FDA has cleared a Deerfield Imaging 510(k) to market its SYMBIS stereotactic brain biopsy system in the U.S. The device allows for a biopsy to be performed while a patient is inside an MRI scanner that is intended to improve targeting and procedure times.
EDAP TMS has received FDA 510(k) clearance to market its Ablatherm Integrated Imaging HIFU (High intensity focused ultrasound) for the ablation of prostate tissue. The HIFU method provides an effective outcome with a low occurrence of side effects, the company says. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.
FDA has cleared two new models in Hitachi Medical Systems America’s Scenaria platform, the SE 64 and SE 128 CT scanners. The company says the models feature added work-flow speed and ease of use capabilities to facilitate the higher daily scanning volumes of busy CT facilities.
FDA has cleared a Kator 510(k) for the Kator Suture Anchor System for use in tissue-to-bone reattachment. “As applied to arthroscopic rotator cuff repair surgery, the system provides knotless fixation with suture anchors that are loaded with four high-strength sutures, with the ability to independently tension each suture,” the company says. Such repairs using a single Kator suture anchor have been shown to have double the fixation strength when compared to repair constructs using certain market leading suture anchors, it says, adding that fewer suture anchors preserves more bone and increases the “footprint” area available for tendon healing.
Mallinckrodt Pharmaceuticals has received FDA clearance for INOmax DS(IR) Plus MRI device indicated for delivery of Inomax (nitric oxide) for inhalation therapy gas into the patient-breathing circuit to provide a constant concentration of nitric oxide to the patient. The company says the device is indicated for use only with Magnetic Resonance Conditional ventilators validated to be compatible, as identified in the device labeling.
FDA has cleared a Perspectum Diagnostics 510(k) for the LiverMultiScan imaging device, which is intended to detect early liver disease using magnetic resonance imaging (MRI). The product was previously introduced in the U.S. as a research device in 2014, and it is currently being used to assess primary endpoints in clinical trials for investigational therapies to treat non-alcoholic fatty liver disease and non-alcoholic steatohepatitis, according to the company. The device is intended to be used in the clinical management of patients with chronic liver disease.
FDA has cleared a Spectranetics 510(k) for its Turbo-Power Laser Atherectomy Catheter and its use in treating in-stent restenosis (ISR). The device “treats at the tip with vaporizing technology for maximal luminal gain,” according to the company. It debulks lesions in a single step and offers remote automatic rotation for “precise directional control,” it adds.
HUMAN DRUGS
FDA has approved a Genentech NDA for Cotellic (cobimetinib) and its use in combination with the company’s Zelboraf (vemurafenib) to treat advanced melanoma that has spread to other parts of the body or can’t be removed by surgery, and that has a certain type of abnormal gene (BRAF V600E or V600K mutation). Cotellic works by blocking the activity of the MEK enzyme, which is part of a larger signaling pathway, the agency says. “Abnormal activity of signaling pathways can lead to cancer. Cotellic prevents or slows cancer cell growth,” it says.
Perrigo has received FDA approval of an ANDA for a generic version of Upsher-Smith Laboratories’ KlorCon (potassium chloride) extended-release tablets (600 mg and 750 mg), indicated for treating and preventing low potassium in the bloodstream (hypokalemia). Combined generic and branded annual sales are about $81 million. Upsher-Smith’s KlorCon is marketed by Sandoz Pharmaceuticals.