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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 used the annual meeting of the Congress of Neurological Surgeons in San Francisco, at which to announce the launch of the first procedure that allows lateral access to the most common operative level of the spine.

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.

The FDA has issued a Class I recall notice on certain product codes and lot numbers of Bard’s LifeStent Solo Vascular Stent, manufactured between November 2011 and June 2012. The reason for the recall is a potential failure to deploy the stent, which would have potentially serious adverse health consequences

Nothing’s perfect, so why regulate it as though it is, goes the argument against tighter regulations. Especially when doing so would mean less innovation, less investment and no obvious reason why patient safety would improve.

The FDA has issued an alert to health care providers and patients concerning its Amplatzer Atrial Septal Occluder (ASO). It seems that in very rare instances, tissue surrounding the device can erode, resulting in life-threatening emergencies that require immediate surgery.

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.

It’s a bit of a “so-what” story really, but when the FDA sends you a warning that you haven’t acted on its observations it is kinda newsworthy. Globus says it’s on top of the situation.

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.

When the boss of a big dog medtech company stands up to speak we all listen. And when he says a combination of FDA rules and medical device sales tax is hurting US industry we cannot disagree. But are these people ignoring the threat of newly restrictive EU regulations?

At this week’s North American Spine Society (NASS) Annual Meeting the company has introduced its Breiten™ Illuminated Retractor System. The system promises to increase surgical efficiency, reduce operating room time and lessen surgeon fatigue by eliminating or reducing dependence on a headlight

TRUMATCH® CMF Solutions Spans Preoperative

Virtual Surgical Planning Services, Intraoperative Tools and Customized Implants

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”