Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. Zimmer Biomet launches Vanguard total knee arthroscopy system
Zimmer Biomet said today it launched the Vanguard individualized total knee arthroplasty implant system.
Warsaw, Ind.-based Zimmer Biomet touted the knee as 1st-of-its-kind, featuring 2 polyethylene bearings with different articulations on the medial and lateral side of the implant to allow surgeons to mix-and-match different bearings to personalize the procedure and preserve soft tissue. Read more
4. FDA approves Bayer’s Kyleena IUD
Bayer said yesterday that it won FDA approval for its hormonal contraceptive device, Kyleena, to prevent pregnancy for up to 5 years.
The German company said the long-acting reversible contraceptive (LARC) is due to hit the market next month. Read more
3. Titan Medical closes $8m offering
Titan Medical said today that it raised nearly $7.9 million (C$10.25 million) via an overnight offering it plans to use to restart the development program for its Sport robot-assisted surgery platform.
The Toronto-based company said it sold almost 17.1 million units at 46.1¢ (C60¢) apiece. The proceeds are slated for the completion of an engineering verification unit, a pair of usability modules and initial usability studies for the Sport program, plus working capital and other uses. Read more
2. FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB
QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon.
The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. Read more
1. FDA approves 6-month endpoint in trial of Bard’s Lutonix 014 drug-coated balloon
C.R. Bard said yesterday that the FDA approved a supplemental investigational device exemption to change the main 6-month endpoint in the clinical trial of a new version of its Lutonix drug-coated balloon in treating below-the-knee peripheral arterial disease.
Murray Hill, N.J.-based Bard in October 2014 won pre-market approval from the FDA for the Lutonix 035 DCB for PAD lesions above the knee. The Lutonix devices are designed to elute the anti-stenosis drug paclitaxel as the balloon is inflated to dilate narrowed arteries. Read more
