Product Approval Summaries

DEVICES

FDA has cleared an Advanced Cooling Therapy 510(k) for the Esophageal Cooling Device for modulating and controlling patient temperature when clinically indicated through a single use, fully-enclosed triple lumen system that is inserted into the esophagus. “Two lumens attach to existing temperature modulation equipment while a third lumen simultaneously allows gastric decompression and drainage,” the company says. The device can be rapidly inserted by most trained health care professionals, in similar fashion to a standard gastric tube, and can be used to control patient temperature in the operating room, recovery room, and emergency room, it says.

Cardica, Inc. has received FDA 510(k) clearance to use its MicroCutter XCHANGE 30 surgical stapling device with a white cartridge for the transection and resection in open or minimally invasive urologic, thoracic, and pediatric surgical procedures.

Centinel Spine has received FDA 510(k) clearance for the ALTOS posterior cervical thoracic stabilization system indicated for use in either the lateral masses of the cervical spine or the pedicles of the cervical-thoracic spine The low profile, stabilization system offers both fully threaded and smooth shank polyaxial screws with 80 degrees of freedom when inserting in demanding spinal anatomies, according to the company. It also provides laminar hooks, connectors, straight and curved rods for customizable constructs.

FDA has cleared an Intuitive Surgical 510(k) for an integrated operating table motion claim for the da Vinci Xi Surgical System. Integrated table motion combines the da Vinci robotic-assisted surgical system and Trumpf Medical’s advanced operating table, the TruSystem 7000dV, to allow surgeons and anesthesiologists the ability to make a range of table adjustments easily during a surgical procedure, according to the company. It also gives operating room teams, while conducting robot-assisted surgery, the ability to leverage the operating table’s capabilities to: position the table so that gravity exposes anatomy during multi-quadrant da Vinci System procedures; maximize reach and access to target anatomy – enabling surgeons to interact with tissue at an ideal working angle; and reposition the table during the procedure to enhance anesthesiologists’ care of the patient.

Pelvalon has received FDA 510(k) clearance for its next generation Eclipse System for women suffering from loss of bowel control. According to the company, it is the first vaginal insert designed to provide immediate bowel control. The original version of the device was granted marketing clearance under the de novo classification process last year.

FDA has granted 510(k) clearance to VGI Medical, LLC to market the VerteLP Lateral Lumber Cage System. According to the company, the cage and integrated plating are delivered in the plane of the disc through a minimally invasive direct lateral approach, so that the implantation may be achieved with less exposure than may be required of other lateral systems with integrated screws that must be inserted at divergent angles, or integrated lateral plates. The company adds that the system features an inserter that delivers the implant and deploys the plating with simple maneuvers.

HUMAN DRUGS

FDA has approved Allergan’s Botox (onabotulinumtoxinA) for treating lower limb spasticity in adult patients to decrease the severity of increased stiffness in ankle and toe muscles. The drug was first approved in 2010 for treating upper limb spasticity (ULS), or increased muscle stiffness in the elbow, wrist and fingers. Additional approval was granted last year to expand its use for treating adults with ULS to include the addition of two thumb muscles.

An Allergan supplemental NDA has also received FDA approval to update the label for Dalvance (dalbavancin) for injection to include a single dose administered as a 30-minute intravenous (IV) infusion for treating acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible Gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus. The company says that Dalvance is the “first and only 30-minute, single-dose treatment option for ABSSSI that delivers a full course of IV therapy, providing an alternative dosing option for physicians.”

FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus FDA has approved an Amgen supplemental NDA for Kyprolis (carfilzomib) for injection in combination with dexamethasone or with lenalidomide plus dexamethasone for treating patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. The agency also approved Kyprolis as a single agent for treating patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. This approval converts to full approval the initial accelerated approval Kyprolis received in 2012 as a single agent.

NextSource Biotechnology has received FDA approval for Gleostine (lomustine) 5 mg capsules for use as a single agent treatment or in combination with other approved chemotherapeutic agents to treat brain tumors—both primary and metastatic, as well as Hodgkin’sdisease.

Novartis has approved Cosentyx (secukinumab) for treating two new indications: adults with active ankylosing spondylitis and active psoriatic arthritis. The company says Cosentyx is the first in a new class of medicines called interleukin-17A (IL-17A) inhibitors.