Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its full line of magnetic resonance imaging safe cardiac resynchronization therapy defibrillators, now approved for use with 3 Tesla MRI machines. The approval includes Fridley, Minn.-based Medtronic’s Claria MRI quad CRT-D SureScan, Amplia MRI quad CRT-D and Compia MRI quad systems, which […]
Medtronic
FDA approves trial for low-risk patients with MDT’s CoreValve Evolut R
Medtronic (NYSE:MDT) said today that the FDA granted an investigational device exemption for a clinical trial of its CoreValve Evolut R implantable heart valve in patients at low risk for adverse events from traditional heart valve replacement surgery. The expanded indication means a likely spring debut for the 1,200-patient trial in patients with severe aortic stenosis with a […]
FDA panel votes against Medtronic’s DIAM spine stabilization system
An FDA advisory panel last week reportedly recommended against approval for the DIAM spinal stabilization system made by Medtronic (NYSE:MDT) The federal safety watchdog’s Orthopaedic & Rehabilitation Devices panel met Feb. 19 to consider the pre-market approval application for DIAM, which stands for “device for intervertebral assisted motion.” It’s designed to treat lower back pain from moderate lumbar degenerative disc disease, at a single […]
NuVasive wins a round in patent battle with Medtronic
NuVasive Inc. (NSDQ:NUVA) this week won a round in its long-standing intellectual property feud with Medtronic (NYSE:MDT) when a federal judge in California found that a patent covering NuVasive’s Osteocel Plus bone matrix does not infringe Medtronic’s IP. Medtronic’s Warsaw unit sued NuVasive in August 2012 in the U.S. District Court for Southern California, alleging that the OsteoCel Plus matrix […]
FDA panel recommends deep, long-term monitoring for leadless pacemakers
An FDA advisory panel yesterday recommended deep, long-term surveillance of the leadless pacemakers being developed by the 4 leading companies in the cardiac rhythm management space. Medtronic (NYSE:MDT), St. Jude Medical (NYSE:STJ), Boston Scientific (NYSE:BSX) and Biotronik are all developing versions of a leadless pacemaker designed to be implanted directly into the heart’s right ventricle, eschewing the need […]
Medtronic touts Solitaire stent retriever meta-analysis
The Solitare stent retriever Medtronic (NYSE:MDT) acquired for $50 billion last year when it bought Covidien is safe and highly effective when combined with standard care using the thrombolysis drug alteplase, according to a meta-analysis of 4 previous trials of the device. The transcatheter Solitaire device uses a stent-like device to trap and retrieve a blood clot in […]
FDA expands approval for Medtronic’s deep-brain stimulation for Parkinson’s
Medtronic (NYSE:MDT) said today that it won expanded approval for its deep-brain stimulation therapy for patients with Parkinson’s disease, which 1st won approval from the safety watchdog in 2002. The expanded approval covers patients who have had a Parkinson’s diagnosis for 4 years and recently developed motor complications, or have long-standing motor complications that can’t be […]
Stryker to pay $1.3B for Physio-Control
Stryker (NYSE:SYK) said today that it agreed to pay $1.28 billion to Bain Capital for automated external defibrillator maker Physio-Control. Medtronic (NYSE:MDT) sold Physio-Control to Bain for $478 million in January 2012. The all-cash deal, slated to close at the beginning of the 2nd quarter, is expected to add slightly to Kalamazoo, Mich.-based Stryker’s adjusted earnings […]
UK’s NICE backs Medtronic’s MiniMed Paradigm Veo
Medtronic (NYSE:MDT) said today the U.K.’s National Institute for Health and Care Excellence issued positive guidance recommending the MiniMed Paradigm Veo insulin pump and integrated glucose sensor for managing type 1 diabetes who experience ‘disabling hypoglycemia.’ Fridley, Minn.-based Medtronic said NICE reviewed 2 sensor-augmented insulin pump therapy systems, and since their assessment recognized Medtronic’s successor system, […]
Fonar taps MR scan inventor and founder’s son as CEO | Personnel Moves
Fonar Corp (NSDQ:FONR) said yesterday it named Timothy Damadian, son of magnetic resonance scanning inventor and company founder Dr. Raymond Damadian, as its new president and CEO. The younger Damadian worked with Fonar for 16 years, eventually becoming veep of operations. He formed Fonar subsidiary Health Management Corporation of America, which manages medial and diagnostic […]
Medtronic launches Valiant TAAA stent graft study
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in a clinical study of its Valiant TAAA stent graft system designed as a minimally invasive treatment for thoracoabdominal aortic aneurysm. The Valiant TAAA stent graft system is designed to operate as an off-the-shelf endovascular solution for patients suffering from aortic aneurysms, which are dangerous bulging or […]