Royal Philips (NYSE:PHG) said today that two of the company’s new Stellarex drug-coated balloons received FDA approval for the treatment of upper leg artery blockages. The approval was for both de novo and restenotic lesions in upper leg arteries. The Amsterdam-based company said the new low-dose (200 mm and 150 mm) balloons will be added to […]
Royal Philips
Philips touts Stellarex balloon study
Royal Philips (NYSE:PHG) said today that third-party data from worldwide clinical trials for the Stellarex drug-coated balloon showed that there was no difference in mortality between patients treated with the device compared to uncoated percutaneous transluminal angioplasty. The primary analysis consisted of three-year patient-level data from the Illumenate pivotal trial and the Illumenate European randomized controlled […]
FDA panel wants more, better data on paclitaxel-eluting devices
An FDA advisory panel on paclitaxel-eluting devices for treating peripheral artery disease yesterday found that the mortality signal indicated by a meta-analysis last year exists but that further study is needed to determine whether it’s a class effect and to pin down the cause of death. A meta-analysis published in the Journal of the American Heart Assn. last December […]
Philips touts Stellarex drug-coated balloon data
Patients using Royal Philips’s (NYSE:PHG) Stellarex drug-coated balloon maintained blood flow through the treated segment of diseased arteries at three years in a pair of clinical trials. Stellarex is designed to restore and maintain blood flow in the superficial femoral artery and peripheral arteries. It’s coated using the company’s EnduraCoat technology to elute the drug paclitaxel. […]
Medtech stories we missed this week: June 8, 2018
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press releasethat it has received FDA 510(k) clearance for its Ingenia Elition […]
These 10 medtech companies care a lot about research
Among the world’s largest medtech companies, these 10 spent the largest portion of their budgets on research and development. So what have they produced? Every year, Medical Design & Outsourcing pulls financial regulatory filings and reaches out to major, companies in some cases to create a list of the 100 largest medical device companies in […]
ASTRO ’17 Round-up: Novocure touts five-year results for Optune, chemo combo in newly-diagnosed glioblastoma patients
Novocure (NSDQ:NVCR) touted data today from the Phase III pivotal trial of its Optune device in combination with temozolomide for the treatment of newly-diagnosed glioblastoma. The analyses were presented at the American Society for Radiation Oncology’s 2017 annual meeting in San Diego. The company’s EF-14 trial showed unprecedented five-year survival results in patients with newly-diagnosed GBM, […]
VIVA 17 Round-up: Medtronic touts real-world data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference. The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study. Data from the In.Pact Global study showed a 83.3% rate of freedom from clinically-driven target […]
Philips, Illumina to launch precision medicine cancer program with Navican
Royal Philips (NYSE:PHG) and Intermountain Healthcare company Navican inked an agreement today to launch a precision health informatics solution aimed at improving outcomes for late stage cancer patients. The program is slated to leverage Navican‘s TheraMap Precision Cancer Care services and Philips’ IntelliSpace Genomics platform, which uses Illumina‘s next-gen genomic sequencing technologies. At Utah-based Intermountain Healthcare’s […]
Philips sees image-guided therapy transforming healthcare: Here’s how
Officials at medtech giant Royal Philips see image-guided therapy as key when it comes to health practitioners providing care that is both efficient and effective. The Dutch multinational’s work in the field provides a great example of how the ever-growing need for cost-effective healthcare around the world is driving the strategies of medical device companies. […]
