Medtronic (NYSE:MDT) said today it won expanded approval from the FDA for its Infuse bone growth protein implant, marking the second expansion for the implant over the past two years. The Infuse implant contains the active ingredient rhBMP-2, a manufactured version of a bone growth protein normally present in the body. The Infuse device is […]
Medtronic
Medtronic dropped from Infuse trial, implanting doc acquitted by jury
A surgeon who used one of Medtronic‘s (NYSE:MDT) controversial InFuse bone-growth protein spinal implants in an “off-label” lumbar procedure has been acquitted by a California state jury, after Medtronic had already been dropped from the case as a defendant, according to the Courtroom View Network. The surgeon, Dr. William Dobkin, was found not negligent in […]
Medtronic touts two-year Harmony transcath pulmonary valve feasibility study data
Medtronic (NYSE:MDT) today released two-year outcomes from an early feasibility study of its Harmony transcatheter pulmonary valve, touting solid valve function no reports of paravalvular leaks. Results were presented at the Society for Cardiovascular Angiography and Interventions 41st annual scientific sessions, the Fridley, Minn.-based company said. “Following the one-year feasibility outcomes, we are encouraged to see […]
Medtronic spinout Inspire Medical sets range for $75m IPO
Inspire Medical Systems this week set the range for a proposed initial public offering that would fetch $75 million at the midpoint. Maple Grove, Minn.-based Inspire, which spun out from Medtronic (NYSE:MDT) in 2007, makes devices for treating obstructive sleep apnea. The company said it plans to issue 5 million shares at $14 to $16 apiece, setting its […]
Medtronic extends afib clinical trial support agreement with Arca Biopharma
Arca Biopharma said today it extended a US, Canadian and European clinical trial collaboration deal with medtech giant Medtronic (NYSE:MDT) for an additional year, now slated to continue until April 2019. Through the deal, Medtronic will support clinical trial use of its monitoring devices, collection of managed atrial fibrillation burden data and managed analysis of cardiac rhythms […]
FDA approves Medtronic’s drug-coated balloon to treat long superficial femoral artery lesions
The FDA approved Medtronic‘s (NYSE:MDT) In.Pact Admiral drug-coated balloon to treat long superficial femoral artery lesions up to 360mm in patients with peripheral artery disease, the medtech giant touted today. In a 227-patient global trial, participants treated with Medtronic’s drug-device combination therapy had a one-year patency rate of 89.1% and a clinically-driven target revascularization rate […]
Medtronic launches OptiSphere embolization spheres
Medtronic (NYSE:MDT) said today it launched its OptiSphere embolization spheres designed for embolization of hypervascular tumors. The Fridley, Minn.-based company said that the embolization spheres, which are manufactured by the Vascular Solutions subsidiary of Teleflex (NYSE:TFX), are designed as a resorbable embolic alternative treatment option to permanent embolics. “Teleflex is very pleased to have Medtronic as a […]
Medtronic taps Harvard cardiologist Mauri for clinical research VP | Personnel Moves – April 10, 2018
Medtronic (NYSE:MDT) said last week it tapped Harvard Medical School professor and cardiologist Dr. Laura Mauri as its new vice president of global clinical research and analytics. In the new position, Dr. Mauri will direct dynamic global clinical research strategies as well as the development of novel analytical and data science solutions as the Fridley, Minn.-baesd […]
Medtronic wins CE Mark for Visualase brain surgery device
Medtronic (NYSE:MDT) said today that it won CE Mark approval in the European Union for its Visualase brain surgery device. Fridley, Minn.-based Medtronic said the MRI-guided Visualase system uses a small-diameter probe to deliver laser energy to ablate soft tissue in the brain. It’s been approved in the U.S. since 2007, the company said. “The introduction […]
Renal denervation: Medtronic wins FDA nod for U.S. pivotal trial
Medtronic (NYSE:MDT) said today that it won an investigational device exemption from the FDA for a pivotal trial of its Symplicity Spyral renal denervation device for treating high blood pressure. Back in January 2014, Fridley, Minn.-based Medtronic shocked medtech when it announced that the highly anticipated Symplicity HTN-3 trial, examining ablation of the nerves around the […]
Medtronic plans $1.2B debt, share buyback plan
Medtronic (NYSE:MDT) said today it is launching a $1.2 billion share and debt buyback effort, looking to redeem the full amount over the course of its 2019 fiscal year. The Fridley, Minn.-based company said it expects to redeem $400 million in 5.6% senior notes due 2019 and $765.6 million in 4.45% senior notes due 2020, which a […]