SAN CLEMENTE, CA — November 6, 2023 — Reflow Medical announced one-year results of the DEEPER OUS clinical trial (NCT04162418) evaluating the company’s Bare Temporary Spur Stent System. Results were presented by Prof. Thomas Zeller, M.D. at the Late Breaking Clinical Trial session at the VIVA2023 conference, sponsored by The VIVA Foundation and held in Las Vegas, Nevada, October 30th–November 2nd.
The goal of the 107-patient, prospective, non-randomized, multicenter, single-arm study is to evaluate the safety and efficacy of the Bare Temporary Spur Stent System in combination with a paclitaxel-coated balloon for the treatment of patients with below-the-knee arterial disease. The population evaluated had multiple comorbidities, with approximately 75% of the patients presenting with nonhealing wounds; approximately 70% with diabetes, and 35% with chronic kidney disease, a comorbidity often excluded from similar trials. Treated lesion lengths ranged from 60-240 mm, averaging 92.7 mm.
Prof. Zeller, a vascular medicine specialist at Universitätsklinikum Freiberg in Bad Krozingen, Germany, and an investigator for the study, summarized the results as follows:
• At 12 months, 74.4% of modified intention to treat (mITT) patients and 79.2% of patients per protocol (PP) showed primary patency of the target lesion.
• 89.5% of mITT and 88.8% of PP patients were free of clinically driven target lesion revascularization (CD-TLR).
• The secondary safety endpoint of freedom from major amputation of a lower extremity (MALE) was 98.9% of mITT and 100% PP of patients at one year.
“We observed a statistically significant reduction in Rutherford class scores and wound healing at six months, with sustained improvement in these clinical outcomes through 12 months,” said Prof. Zeller. “These results confirm the promise of the Temporary Spur Stent for treating patients suffering from peripheral artery disease (PAD) and critical limb-threatening ischemia (CLTI).”
Retrievable Stent Therapy or RST describes the novel “retrievable” design of the Spur self-expanding nitinol stent, which is removed after stent expansion and therapy, leaving no metal behind. The device includes radially expandable spikes that may modify plaque, help prevent recoil, and may reduce dissections while improving drug uptake when used with a drug-coated balloon (DCB).
According to Reflow Medical’s CEO and Co-Founder, Isa Rizk, “Our patented retrievable stent therapy is designed to maximize the benefits of stent therapy while minimizing the long-term implant risk. The one-year results of the DEEPER OUS study show we’re one step closer to filling an unmet need, helping physicians successfully treat advanced below-the-knee disease.”
Ten centers in the EU and New Zealand participated in the study. The Bare Temporary Spur Stent is for investigational use only.
About Reflow Medical, Inc.
Reflow Medical, Inc. is a private company focused on empowering physicians through the design and development of innovative and effective technologies for treating cardiovascular disease. Their goal is to respond to physicians’ need for advanced treatments for patients with peripheral artery disease, including chronic limb-threatening ischemia, and complex coronary artery disease.
Contact: Jennifer Carlyle