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
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 […]
Researchers’ bionic pancreas outperforms standard insulin pump therapy
Researchers from Boston University have developed a bionic pancreas system that outperformed conventional insulin pump therapy for patients with type 1 diabetes, according to a trial conducted at Massachusetts General Hospital. The team’s work was published in The Lancet. This device is the latest development in the race to make an entirely closed loop insulin pump system, […]
Medtronic secures Health Canada license for MiniMed 630G system
Medtronic (NYSE:MDT) subsidiary Medtronic Canada said today that it landed a license with Health Canada for its MiniMed 630G insulin pump system for patients with diabetes mellitus. The Fridley, Minn.-based company said it interviewed more than 1,000 diabetes patients to better understand the features they look for in an insulin pump. The final product has a […]
Report: Drug device market to reach $1.8B by 2024
The global drug device combination market is expected to reach $17.7 billion by 2024, according to a new report from Grand View Research. The report points to minimally invasive alternatives like transdermal patches as high-impact growth drivers in the industry. As researchers develop these products, regulatory agencies have taken notice and the report notes that […]
Ablative Solutions wins FDA nod for Phase II chemical denervation trial
Ablative Solutions said today that the FDA approved a Phase II trial of its chemical denervation system for hypertension under its investigational new drug application. The trial, called Target-BP I, will evaluate the efficacy of Ablative’s Peregrine infusion ablation system, which uses ethanol to interrupt signals from sympathetic nerves in the renal artery to control […]
Medtronic wins CE Mark for In.Pact Admiral DCB for end-stage renal disease
Medtronic (NYSE:MDT) said today its In.Pact admiral drug eluting balloon won CE Mark approval in the European Union for arteriovenous access to help maintain hemodialysis access in patients with end-stage renal disease. The device is now cleared for preventing restenosis in hemodialysis access sites by opening up the artery and delivering paclitaxel to the vessel wall. […]
Diabetes: Medtronic furthers the quest for an artificial pancreas
Medtronic (NYSE:MDT) and Intarcia Therapeutics were in the spotlight at the American Diabetes Assn.’s annual scientific sessions conference in Boston last week, revealing new medical device developments in the fight against diabetes. Medtronic took center stage, announcing new developments for its artificial pancreas program, touting positive data from a user study of its MiniMed 640g and revealing plans to collaborate […]
