Reflow Medical announced that investigators enrolled the first patients in a trial of its Spur sirolimus-eluting retrievable scaffold system. DEEPER CORONARY evaluates the Spur Elute stent as a primary treatment for in-stent restenosis (ISR) of the coronary arteries. Spur Elute offers a treatment by transferring a proprietary drug formulation to the diseased lesion without leaving […]
ReFlow Medical
Reflow Medical wins FDA breakthrough nod for Temporary Spur Stent System
Reflow Medical announced yesterday that its Temporary Spur Stent system for treating below-the-knee peripheral artery disease (PAD) won FDA breakthrough device designation. The Temporary Spur Stent system includes radially expandable spikes designed to create multiple pathways for delivering antiproliferative drugs for increased uptake into the vessel wall for facilitating acute luminal gain without leaving anything […]
Reflow Medical launches chronic total occlusion study of Wingman caths
Reflow Medical said yesterday it launched a clinical study of its Reflow Wingman catheters exploring the device’s ability to cross chronic total occlusions in peripheral lesions. The first patients in the study, dubbed the Wing-It trial, have already been enrolled, the San Clemente, Calif.-based company said. Enrollments took place at Springfield, Ill.’s St. John’s Hospital Prairie […]
FDA adds coronary indication to Reflow Medical’s Wingman14C clearance
Reflow Medical said today that it won 510(k) clearance from the FDA for a new indication for its Wingman14C crossing catheter in treating blocked coronary arteries. The Wingman device is already cleared in the U.S. and Europe for treating blocked peripheral vessels, the San Clemente, Calif.-based company said. The device is designed for treating both coronary […]
FDA: ReFlow Wingman35 crossing cath recall is Class I
The FDA today released information on a select recall of ReFlow Medical Wingman35 crossing catheters over issues with device tip splitting or separation, labeling it as Class I. Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health […]
Maquet Medical inks distro deal with ReFlow
Maquet Medical said today it entered an exclusive U.S. distribution agreement with ReFlow Medical to distribute its full line of catheters including the Wingman Crossing catheters and speX shapeable support catheters. Maquet said it will begin distribution of the catheters in the 1st quarter of 2016. “We’ve partnered with ReFlow Medical on this distribution agreement […]
BSX wins CE Mark, FDA approval for spinal cord stims | Regulatory news for the week of October 27, 2014
Boston Scientific wins CE Mark, FDA nod for spinal surgical leads
October 21, 2014 by Brad Perriello
ReFlow has new Wingman35 in U.S. market
On the heels of CE Mark approval in Europe, ReFlow Medical announced FDA clearance for its Wingman35 crossing catheter and said it has already been used in California vascular clinics.
FDA releases final recs on legal exemptions for customized medical devices | Regulatory news for the week of September 29, 2014
ReFlow Medical wins CE Mark for crossing catheters
ReFlow Medical said physicians in Germany are already using its Wingman35 and Spex crossing catheters, after the San Clemente, Calif.-based company won CE Mark approval for both devices for treating lesions in the peripheral vasculature.
