Expanding into Complex Percutaneous Coronary Interventions (PCI) with the introduction of the coraCatheters™ line
We are proud to announce that we received FDA commercial clearance for our new coraCatheters line of microcatheters. “It’s exciting to see a company do the work it takes to produce innovative devices in the coronary space,” said Dr. William Lombardi, a globally recognized physician specializing in complex coronary PCI.
Dr. Lorenzo Azzalini employs a wire escalation strategy using the Reflow coraFlex™ in PCI-CTO case
Six-month clinical trial results reported: DEEPER OUS and the Vessel Recoil Sub-study: Initial Insights, and DEEPER LIMUS
Michael Lichtenberg, MD, FESC, Chief Medical Officer and Director of the Angiology and Vascular Center in Arnsberg, Germany, presented six-month results of the DEEPER OUS clinical trial (NCT03807531) evaluating the safety and efficacy of the Bare Temporary Spur Stent System, followed by a commercially available drug-coated balloon, at the Leipzig Interventional Course, or LINC 2023, held in Germany June 6-9. He noted improvements in the study patients’ Rutherford class scores, with fewer than 8% requiring revascularization during the six-month period.
Thomas Zeller, MD, Chief of the Department of Angiology at University Heart Center also presented results of a DEEPER OUS sub-study evaluating acute vessel recoil at LINC. He reported that in 38 patients with a total of 40 lesions treated with the Bare Temporary Spur Stent System, results demonstrated a reduction in vessel recoil of more than 50%, 42.5% compared to previously reported rates of 97% with percutaneous transluminal angioplasty (PTA), and a trend toward improved six-month patency in subjects without vessel recoil.
Professor Marianne Brodmann, MD, from the Medical University of Graz, Austria, also discussed six-month results of the DEEPER LIMUS clinical trial (NCT04162418) at LINC. This study evaluates the safety of the Bare Temporary Spur Stent System, followed by a commercially available sirolimus-coated balloon. Data for the completed trial will be presented at CIRSE in Copenhagen, September 9-13, 2023.
U.S. Enrollment gains momentum in the DEEPER REVEAL IDE Clinical Trial