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
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 […]
FDA wants answers from Medtronic, St. Jude on leadless pacers
The FDA is hosting a panel meeting on leadless pacemaker devices, looking to St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) to join the discussion and make recommendations on acceptable guidelines on the devices. The panel committee will seek recommendations on clinical trial and post approval study design and physician training, and will be asked to make recommendations […]
FDA approves Medtronic’s Amplia, Compia MRI-safe CRT-Ds
Medtronic (NYSE:MDT) today claimed title to being to only company with cardiac resynchronization therapy defibrillators approved by the FDA for MRI scans. The Fridley, Minn.-based medical device giant said the FDA approved its Amplia and Compia MRI Quad CRT-D SureScan devices for MRI scans on any part of the body without positioning restrictions. Medtronic plans to […]
Medtronic wins expanded PMA for CoreValve
The FDA cleared expanded indications for Medtronic‘s (NYSE:MDT) CoreValve TAVR devices, now cleared for use in patients with end-stage renal disease and those with low-grade, low-flow aortic stenosis. Medtronic won approval from the FDA to modify the CoreValve’s labeling in November which included both its CoreValve and CoreValve Evolut R systems. The changes to the labeling […]
Urologix sold to settle debt to Medtronic
Urologix Inc. (OCT:ULGX) yesterday said it sold almost all of its assets to a secured creditor, which then sold them to a private company that will operate the business as Urologix LLC. The remnants of Urologix Inc. were renamed 21st North Inc. The Minneapolis-based company, which makes the Cooled ThermoTherapy and Prostiva RF devices to treat benign […]