QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation. The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy. The pivotal study of QT Vascular’s […]
Vascular
Report: Medtronic, Boston Scientific stand by paclitaxel-eluting devices despite JAHA study
Major medtech players Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate, according to a Star Tribune report. In the meta-analysis, researchers led by Dr. Konstantinos Katsanos analyzed data from 28 […]
Reva brings bioresorbable scaffolds to new markets
Reva Medical (ASX:RVA) said this week that it inked four new distribution agreements, bringing its commercial operations to seven European countries. The San Diego, Calif.-based company said the deals serve to expand the reach of its drug-eluting bioresorbable scaffold, Fantom Encore. Reva said it landed deals with the following companies: A care a.s. in the Czech […]
Ablative Solutions closes $77m Series D
Ablative Solutions said today that it closed a $77 million Series D funding round slated to help support its technology platform intended to treat hypertension. The round was led by newly invested Gilde Healthcare and co-led by existing investor BioStar Ventures and an undisclosed new strategic corporate investor, the Kalamazoo, Mich.-based company said. Existing investors […]
Investigators hit pause on trials following concerns over paclitaxel-coated devices
A meta-analysis published in the Journal of the American Heart Association last week suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared to people treated with uncoated balloons. The results of the study prompted investigators for two trials to stop their studies. […]
How Reggie Groves reinvented Medtronic’s atrial fibrillation biz
Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview: When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about […]
Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy
Reva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy. The company’s third-generation coronary bioresorbable scaffold features a thin strut profile and Reva’s Tyrocore polymer. “The patient I treated today was young, only 53 years old, and a perfect candidate for bioresorbable scaffolds,” Antonio Colombo of the Columbus […]
Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold
In a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority. The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. […]
Boston Scientific puts $4B on the table for BTG’s interventional portfolio
Boston Scientific (NYSE:BSX) said today that it agreed to offer $4.24 billion to acquire British medical device maker BTG (LON:BTG) and its portfolio of interventional drug-device therapies. The Marlborough, Mass.-based company said that its acquisition of BTG will augment Boston Scientific’s capabilities in the treatment of cancer and pulmonary embolism. “We are confident that the addition of these therapies […]
Philips launches below-the-knee PAD trial for drug-coated balloon
Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon. The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia. “Several studies have shown the safety and durability […]