Approval/Clearance

Sorin gets CE mark approval for Solo Smart,the evolution of Freedom Solo, a stentless and biological aortic valve with no synthetic material, proven outstanding hemodynamic and clinical performance.

Back in July, Dallen Medical submitted its 510(k) for the Tensyn™ band for fixation of ankle syndesmosis. Now the company is reporting that the FDA has duly cleared the product for market.

Boston Scientific’s FDA cleared and CE mark approved new embolectomy catheter features a proprietary shaft design that the company says enables better control In hard-to-navigate Vessels.

Neuro implant developer, NeuroPace has announced the U.S. FDA approval of its RNS Stimulator, a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

Bruin Biometrics, LLC has gained CE Mark approval to market the SEM Scanner in the European Union. The SEM Scanner is that is intended to detect localized tissue edema and pressure induced tissue damage that may lead to the formation of pressure ulcers before damage becomes visible on the skin’s surface.

The ReliantHeart HeartAssist 5®Ventricular Assist Device (VAD) has gained CE Mark approval in Europe for use in patients requiring ventricular support due to end stage heart failure. The HeartAssist 5® is approved for bridge to transplant (BTT) patients awaiting cardiac transplantation and for destination therapy (DT) patients who are not candidates for cardiac transplantation.

Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company, has gained CE Mark clearance for its KXL II System, building on the company’s portfolio of technologies aimed at non-surgical correction of ophthalmic conditions.

Medtronic’s Lead Integrity Alert software is designed to detect implantable pacing lead failures better than impedance monitoring alone. Now the company has gained FDA approval for its system to be used in the detection of problems with other manufacturers’ leads, which opens up a further 12,000 case in the US alone.

Veniti™, Inc., has received approval to CE Mark the Veniti Vici™ Venous Stent, specifically designed for the treatment of venous obstruction. In addition, the company received CE Mark approval for their varicose vein ablation product, the Veniti Veni™ RF Plus Ablation System.

W. L. Gore & Associates has gained CE Mark approval for its GORE EXCLUDER Iliac Branch Endoprosthesis. The company says Excluder is the first complete, fully engineered system intended for endovascular treatment of common iliac artery aneurysms or aorto-iliac aneurysms.

Biotronik has seen its clever, electrospun coated stent gain CE mark approval for use in cases of acute coronary vessel perforation. The clever part lies in the electrospinning, which creates a single, integrated coating without the need to sandwich the stent.

Diabetes solutions giant Novo Nordisk, has gained FDA approval for its pre-filled insulin pens which it says avoid the patient challenges presented by other pre-filled pens.

Its been a good week for Reverse Medical Corporation, which has seen CE Mark approval, FDA 510k clearance and initial clinical use of its ReVerse® Microcatheter product line for intracranial neurovascular use.

FDA’s Mitraclip approval now means it’s available in the United States for patients with significant symptomatic degenerative MR who are at prohibitive risk for mitral valve surgery. New data at TCT2013 provides compelling clinical support for the device in this patient group.

Neuromonitoring device company Raumedic has gained FDA 510(k) clearance to market Neurovent®-PTO. The company says this is the only marketed device that combines measurement of intracranial pressure , intracranial temperature and oxygen partial pressure in one Catheter.

MIS spine developer NLT Spine, has seen two of its generation 2.0 products designed for spinal fusion procedures received FDA 510(k) clearance. PROW FUSION™ and eSPIN™ both target the lumbar interbody fusion market, which currently represents an opportunity of approximately $1.3 billion globally.