Approval/Clearance

MIS device company, AngioDynamics has gained CE Mark approval for its AngioVac venous drainage cannula and cardiopulmonary bypass circuit for use during extracorporeal bypass for up to six hours. Under the CE Mark approval the AngioVac cannula is also approved for removal of fresh, soft thrombi or emboli.

Boston Scientific’s Lotus™ Transcatheter Aortic Valve Implant has gained CE Mark approval as a treatment alternative for patients with severe aortic stenosis at high risk with surgical valve replacement.

Back in March things were looking a little up in the air for MitraClip as the FDA’s circulatory devices panel gave the clever device its thumbs up, despite the FDA’s summary document at the time saying there were still concerns. Seven months on and the device has received its US approval and will launch immediately in the United States.

Cardiovascular Systems, Inc. has received FDA PMA approval for its Diamondback 360® Coronary Orbital Atherectomy System, the first such device to gain approval as a treatment for severely calcified coronary arteries for over twenty years.

TCT2013 will see St. Jude Medical, Inc. showcasing its newly FDA approved ILUMIEN™ OPTIS™ PCI Optimization™ System, a new technology designed to provide physicians with a comprehensive disease assessment tool for treating patients with coronary artery disease.

Radiotherapy expert Varian Medical Systems has received 510(k) clearance from the U.S. FDA for a radiotherapy treatment planning tool designed to enhance quality, consistency, and efficiency in radiotherapy treatment planning.

Medtronic, Inc. has announced the U.S. launch of its Export Advance aspiration catheter, which it says offers greater power and superior deliverability in coronary artery thrombus removal.

Neurovascular technology company Pulsar Vascular has received European CE Mark approval for its lead product, the PulseRider®. The company says its device is designed to treat brain aneurysms in conjunction with embolic coils or flow diversion devices.

Guided Therapeutics has still not addressed all of the FDA’s concerns as it attempts to gain PMA approval for the LuViva cervical scanning device. It’s consoling itself with revenue from a newly enhanced push into more international markets.

Irish MIS device company Crospon tells us it has received US FDA clearance for its EsoFLIP® balloon dilation catheter. The device is complementary to the Crospon’s EndoFLIP® measurement device and represents the company’s first foray into endoscopic therapeutic products.

Ingeniously, the newly FDA cleared Hollywood Nanometalene IBD from Integra comprises a PEEK-OPTIMA core construct, coated with an ultrathin layer of titanium, providing the best of both worlds in Interbody Device design.

It’s 18 months since minimally invasive spine technology company K2M, Inc., gained FDA clearance for its Santorini® Corpectomy cage system. … continue reading “K2M Launches SANTORINI® Small Corpectomy Cage at NASS”

CIVCO Medical Solutions has gained FDA clearance of its Protura™ Robotic Patient Positioning System integration with Varian Medical Systems’ Motion Management Interface. The system delivers accurate patient positioning, one of the most important issues in radiation oncology

Advanced Catheter Therapies, Inc. has gained FDA clearance for its clever multi-lumen Occlusion Perfusion Catheter™. The device enables the operating physician to occlude and isolate a section of vessel and deliver a therapeutic agent in a controlled and effective manner.

Binder Biomedical Inc. has announced that its new LOGIC intervertebral body fusion device has been cleared by the FDA. The complete anterior lumbar fixation system will see its initial launch early next year.

Zilico Ltd has gained CE Mark certification for its cervical cancer diagnostics device, ZedScan™ I. The UK company’s ground-breaking system offers quick, accurate detection of cervical neoplasia in real-time, enabling clinicians to improve patient management.