Medtronic (NYSE:MDT) said yesterday it enrolled the 1st patients in the VIVA-sponsored Reality study assessing outcomes of peripheral artery disease patients treated with directional atherectomy and drug-coated balloons. The study is slated to enroll up to 250 subjects across 15 sites, investigating the use of Medtronic’s HawkOne, TurboHawk and In.Pact Admiral DCB for calcified and […]
Medtronic
Heartware Q2 sees losses shrink, beats the street
HeartWare International (NSDQ:HTWR) today released 2nd quarter earnings that beat the Street alongside shrinking losses as the company is slated to be picked up Medtronic (NYSE:MDT) in a $1.1 billion deal. The Framingham, Mass.-based company, reported losses of $10.9 million, or 62¢ per share, on sales of $68.7 million for the 3 months ended June 30. The […]
New crop of robots to vie for space in the operating room
(Reuters) – Even though many doctors see need for improvement, surgical robots are poised for big gains in operating rooms around the world. Within 5 years, 1 in 3 U.S. surgeries – more than double current levels – is expected to be performed with robotic systems, with surgeons sitting at computer consoles guiding mechanical arms. Companies developing new […]
Medtronic launches VariLock plate system in China
Medtronic (NYSE:MDT) said today it is launching its VariLoc locking compression plate system designed for treating bone fractures in China and a select number of other countries. The VariLoc system is designed with variable angle locking technology to allow surgeons to adapt screw angulations to specific patient anatomy, capture fracture fragments, fine-tune screw trajectory post-plate […]
India’s proposed stent pricing cap said to squash new product introductions
India’s move toward capping the price on coronary stents reportedly has medical device makers rethinking their strategies there and even shelving new product rollouts. “With price controls, margins of all players including manufacturers will be impacted. Global stent makers may scale back introducing their top-of-the-line brands and launch value products instead,” Rana Mehta, healthcare leader at PwC […]
Medtronic recalls pacing leads on design standards snafu
Updated to include comment from Medtronic Medtronic (NYSE:MDT) last month recalled 1 of its temporary pacing leads due to a design standards snafu. In a June 16 letter to customers who bought the leads, Fridley, Minn.-based Medtronic said its Model 6416 temporary transvenous pacing leads are not compliant with standards set by the FDA and the International […]
Medtronic wins 1st FDA nod for cement-augmented spine screws
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its CD Horizon fenestrated cement-augmented spinal pedicle screw set, designed to be used with Medtronic’s HV-R polymethylmethacrylate fenestrated screw cement. The company touted the win as the 1st FDA approval for cement-augmented pedicle screws. The newly FDA cleared screw set is indicated for use at […]
Medtronic wins CE Mark for Guardian Connect mobile CGM
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European union for its Guardian Connect mobile continuous glucose monitoring system. The Fridley, Minn.-based medical giant said it is the 1st smartphone-enabled CGM system to win CE Mark approval for the company, and expects to launch the device on a country-by-country basis in the […]
Medtronic wins FDA nod for 2-level cervical fusion with Prestige LP spine implant
Medtronic (NYSE:MDT) said today that the FDA approved 2-level cervical fusions using its Prestige LP spinal implant. “Medtronic is committed to elevating spine care by combining innovative new technologies with clinical evidence,” Medtronic Spine president Doug King said in prepared remarks. “The Prestige LP Disc is a superior alternative to [anterior cervical discectomy & fusion] and an […]
Medtronic launches new oblique lateral spine tech
Medtronic (NYSE:MDT) said today that it’s launching several new components for its oblique lateral spinal fusion system. Fridley, Minn.-based Medtronic said the Pivox system for its OLIF25 and Divergence-L for the OLIF51 system are slated to debut at the International Meeting on Advanced Spine Techniques in Washington this week. The OLIF procedures are designed to minimize […]
FDA approves longer version of Medtronic’s In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) said today that the FDA approved a longer version of its In.Pact Admiral drug-coated balloon for treating peripheral artery disease. The 150mm-lenth device is available in 4mm, 5mm and 6mm diameters, the Fridley, Minn.-based company said. The FDA originally cleared the In.Pact Admiral DCB in January 2015, about 6 years after it won […]