Cagent Vascular LLC. has received FDA clearance for its Serranator Alto PTA serration balloon catheter. The Wayne, Pa.-based company's device is the first of a family of peripheral artery disease (PAD) technologies under development which incorporate the company's serration technology in an angioplasty balloon. The private company's device is indicated for dilatation of lesions in the iliac, femoral, iliofemoral and popliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. "The whole concept behind the Serranator Alto PTA device is to create these longitudinal lines of interrupted micro serration,"...

PARIS – The CE mark is dead, long live the new CE mark. Five years after launching a reform of regulations for commercializing medical devices and in vitro diagnostics (IVDs), the European Council released the final text for the Medical Device Regulations (MDR) and IVD Regulations (IVDR), setting in motion a countdown to enforcement. "The future is in this version and like it or not, this is what we will work with, what we need to make a success, because the alternative that it does not work is so much worse," said Ronald Boumans, the...

Boston Scientific Corp. said it was recalling its previous generation Lotus heart valve replacement devices following reports of problems with the products' locking mechanisms. The Marlborough, Mass.-based company said the issue stems from excess tension in the pin mechanism that was introduced during the manufacturing process. News of the recall caused the devicemaker's (NYSE:BSX) shares to temporarily plummet by 8 percent on Thursday morning. By closing the shares were down about 2.68 percent, closing at $24.48. Boston Scientific spokeswoman, Timette Nevala, told Medical Device Daily, that Thursday's recall was a "result of a number of...

Medtronic plc revealed strong 3Q17 sales in its most recent earnings, distancing itself from a relatively bleak 2Q17. The Dublin-based company's revenue grew about six percent during the three months ending on Jan. 27 compared to the same period last year. Strong sales also boosted Medtronic's adjusted income up 3.3 percent to $1.5 billion, on total sales of $7.28 billion during the quarter. With these earnings the company is rebounding from a period of stalled growth. "The 6 percent growth in the quarter dispelled some of the concerns that last quarter's 3 percent, including 1...

The Global Regulatory landscape for Medical Devices has never been simple, but recent developments have opened new trap doors for the unwary device manufacturer. Join us for a live webinar on February 28 or March 2 featuring the editors of Medical Device Daily and Cortellis Regulatory Intelligence to understand the critical recent developments in the global medical devices regulatory scene and how to stay ahead. REGISTER NOW: February 28, 2017 San Francisco, 9 a.m. / New York, Noon / London, 5 p.m. / Paris, 6 p.m. March 2, 2017 New York, 9 a.m. / London, 2 p.m. / Paris, 3 p.m.    ...

Medrobotics Corp. has closed on a $20 million preferred stock financing. Proceeds will be used to fund the Raynham, Mass.-based company's expansion into new surgical applications for its Flex Robotic System. The company first gained FDA clearance for the device in 2015 for transoral applications in the ear, nose and throat, and it has had CE mark for colorectal applications using a transanal approach since 2014. "The Flex Robotic System is a steerable sheathable platform, and it's not limited to line of site access for surgical targets," Tom Patzelt, vice president of marketing for Medrobotics,...

Diabetes patients could receive more benefit from more noninvasive approaches to checking for glucose levels than the traditional finger-stick method. Abbott Laboratories Inc. released data from a study showing patients who scan more frequently with the company's Freestyle Libre system spend less time in hypoglycemia or hyperglycemia while having improved average glucose levels. The real-world data findings were presented at the Advanced Technologies and Treatment for Diabetes congress in Paris, last week. The full data set was generated from 50,831 readers, which were used to scan 279,446 sensors. According to the data, people with diabetes...

Ophthalmic technology specialist Glaukos Corp. has completed patient enrollment in the pivotal phase of its investigational device exemption trial for the Istent Supra Suprachoroidal Micro-Bypass Stent. The San Clemente, Calif.-based company's clinical trial includes 36 sites and 505 subjects with mild-to-moderate primary open-angle glaucoma and cataracts. Subjects were randomized to receive either Istent Supra in combination with cataract surgery or cataract surgery alone. The study has a 24-month primary outcome measure of a 20 percent or greater reduction in intraocular pressure (IOP) from baseline. The Istent Supra is designed to reduce IOP by accessing the...

Integra Lifesciences Holding Corp. has made a bid to acquire Johnson & Johnson Corp.'s (J&J) Codman Neurosurgery business for $1.05 billion in cash. The neurosurgery business is part of New Brunswick, N.J.-based J&J's Depuy Synthes unit and brought in sales of $370 million last year. Plainsboro, N.J.-based Integra, which makes products used in neurosurgery, reconstruction, wound and dental care, said the Codman business, could bolster its pipeline of offerings for tissue ablation, spinal cord repair and cranial stabilization. Integra executives said this is the largest acquisition in the history of the company. The transaction is...

Diagnostics specialist Hologic Inc. is slated to become the newest player in the aesthetics market with its proposed acquisition of Westford, Mass.-based Cynosure Inc. for $1.65 billion. Shares of Cynosure (NASDAQ:CYNO) jumped about 28 percent in trading to $65.95, on Tuesday. Bedford, Mass.-based Hologic executives said the all-cash deal could close in either late March or April. This marks the second acquisition in the aesthetics space this week. On Monday, Dublin-based Allergan plc revealed its plan to acquire body contouring specialist Zeltiq Aesthetics Inc. for $2.48 billion. (See Medical Device Daily, Feb. 14, 2017.) Hologic...