Medtronic (NYSE:MDT) touted 1 year data from the In.Pact SFA Japan trial of its drug-coated balloon compared to plain balloon angioplasty. The company also said today it won regulatory approval in Canada for its In.Pact Admiral DCB in patients with peripheral artery disease in the upper leg. The trial enrolled 100 patients, 68 of whom […]
Medtronic
NIH launches pivotal trials for artificial pancreas
The National Institutes of Health said this week that it is funding 4 projects dedicated to testing fully automated artificial pancreas devices in patients with Type I diabetes. The race to develop an artificial pancreas met a milestone last year, after the FDA approved Medtronic’s (NYSE:MDT) hybrid model of an artificial pancreas – the 1st of its kind […]
Medtronic wins VA telehealth supply contract
Medtronic (NYSE:MDT) said today its Medtronic Care Management Services won a contract from the US Department of Veterans Affairs to provide home telehealth technologies. The contract will position Fridley, Minn.-based Medtronic’s CMS to provide veterans with telehealth technology platforms including connected diagnostic devices, clinical workflow software and related telehealth solutions for 1 year, with 4 optional […]
UPDATE: Medtronic looks to sell $5B medical supplies biz
Medtronic (NYSE:MDT) is working with advisors for a possible sale of its medical supplies business, according to a Bloomberg report. The process is reportedly in an early stage, but the Fridley, Minn.-based company has been looking for prospective buyers for the division, which could be worth $5 billion. The sale could happen in a single […]
Medtronic wins FDA clearance for CardioInsight 3D mapping tech
Medtronic (NYSE:MDT) said today that it won 510(k) clearance from the FDA for its CardioInsight Noninvasive 3D mapping system, which was designed to map irregular heart rhythms in the upper and lower chambers of the heart and provide electroanatomic 3D maps of the heart. The CardioInsight system is the 1st commercially available, noninvasive cardiac electrical […]
Judge pares $20m verdict in doc’s patent spat with Medtronic
A federal judge in Texas reduced a $20.3 million verdict against Medtronic (NYSE:MDT) by $2.6 million this week, ruling that Dr. Mark Barry did not present sufficient evidence that the company infringed 1 of its patents overseas. The judge from the District Court for Eastern Texas upheld that the company infringed 2 device patents in the […]
Medtronic wins CMS coverage for Micra leadless pacer
Medtronic (NYSE:MDT) said today the U.S. Centers for Medicare and Medicaid Services released a National Coverage Determination which will cover leadless cardiac pacemakers, including the company’s Micra TPS. With the designation, Medicare patients will have access to Fridley, Minn.-based Medtronic’s Micra through Medicare’s policy of Coverage with Evidence Development, the company said. The Micra transcatheter pacing system, which […]
FDA OKs Medtronic trial for In.Pact Admiral DCB in renal disease
Medtronic (NYSE:MDT) said today that the FDA approved its investigational device exemption application for a study to evaluate its In.Pact Admiral drug-coated balloon in patients with end-stage renal disease. The Fridley, Minn.-based company said that its study will compare its DCB to plain balloon angioplasty as a treatment for failing arteriovenous fistulas. The primary efficacy endpoint […]
Medtronic touts In.Pact Admiral drug-coated balloon data
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon in patients with peripheral arterial disease. The company presented outcomes from its In.Pact Global study patient cohorts in Asia and Belgium, concluding that its DCB demonstrated consistent outcomes across patient populations. More than 96% of the 114-patient study group in Asia achieved positive outcomes, which […]
Report: IRS agrees to slash Medtronic’s $1.4B transfer pricing tax tab by an order of magnitude
The U.S. Internal Revenue Service reportedly agreed to drastically slash the amount it claims Medtronic (NYSE:MDT) owes on loans between its subsidiaries, from a potential $1.36 billion to just $14 million. Last summer, a federal tax judge found for the Fridley, Minn.-based company in its lawsuit against the IRS over the dispute, which involves “transfer pricing” among the […]
Medtronic launches trial for Visualase MRI-Guided laser ablation device in epilepsy patients
Medtronic (NYSE:MDT) said today that the 1st procedure using the Visualase MRI-Guided laser ablation system has been performed in its SLATE clinical trial evaluating the device in patients with drug-resistant mesial temporal lobe epilepsy. The trial is slated to enroll 120 patients with MTLE, the most common form of epilepsy. Researchers will observe the patients […]