C.R. Bard (NYSE:BCR) said it expects to file the final module in its pre-market approval application with the FDA for the Lutonix drug-eluting balloon after a clinical trial met its primary endpoints for efficacy and safety.
Peripheral
Covidien’s got a ‘new approach’ to peripheral arterial disease
Abbott closes $310M IDEV Technologies buy
AxoGen raises $18M in support of its peripheral nerve repair products
PAD: Medtronic files for FDA approval of drug-eluting balloon
Medtronic (NYSE:MDT) applied for pre-market approval from the FDA for a medical device designed to treat peripheral artery disease, the In.Pact Admiral drug-eluting balloon.
Fridley, Minn.-based Medtronic said it’s gearing up for a full launch in the U.S. in 2015, assuming the FDA approves the application.
Cook Medical gets its Zilver PTX back on the market
Three months after the recall of its Zilver PTX peripheral stent, Cook Medical has the device back on the market across the globe.
Rob Lyles, vice president and global leader of Cook’s peripheral intervention business, told MassDevice.com today that the FDA cleared the device to go back on the U.S. market July 25.
Covidien launches 2 trials to support its Stellarex drug-device combo
Abbott acquires IDEV Technologies, OptiMedica
Abbott (NYSE:ABT) said it agreed to acquire a pair of companies in the peripheral stent and ophthalmic space for a total of up to $710 million.
The Chicago-ares medical device company said it inked a deal worth $310 million for Webster, Texas-based IDEV Technologies and its Supera Veritas stent for treating peripheral artery disease.
C.R. Bard enrolls 1st patient in U.S. trial of below-the-knee PAD
Cardiovascular Systems launches post-market trial of PAD devices
Cardiovascular Systems (NSDQ:CSII) launched its Liberty 360° trial, a post-market evaluation of medical and economic outcomes for difficult-to-treat peripheral arterial disease cases.
Cook Medical’s Zilver Vena venous self-expanding stent trial is a 1st for the U.S.
Indiana medical device giant Cook Medical announced the launch of a new clinical study, the 1st of its kind evaluating the safety and effectiveness of its Zilver Vena venous self-expanding stent.
The VIVO study will enroll select adult patients experiencing limiting leg pain, leg swelling or skin discoloration or a healed or active lower leg ulcer, according to a Cook statement.