CE Mark Certification for the Bare Temporary Spur Stent System
Reflow has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System for treating de novo or restenotic below-the-knee (BTK) lesions in the infrapopliteal arteries in conjunction with a commercially available drug-coated balloon (DCB).
The Bare Temporary Spur Stent System is designed to deliver a temporary, retrievable stent to the peripheral (infrapopliteal) vasculature. This unique clinical solution, known as Retrievable Stent Therapy, or RST, is intended to provide stent-like results while leaving no metal behind.
12-month DEEPER OUS data reported at The VIVA23 Conference
Professor Thomas Zeller, MD, presented 1-year results from the DEEPER OUS clinical trial (NCT03807531) at VIVA23. The trial evaluates the safety and efficacy of Reflow’s Bare Temporary Spur Stent System for the treatment of infrapopliteal disease with a commercially available drug-coated balloon (DCB).
One-year results of the DEEPER OUS clinical trial (NCT03807531) evaluating the Bare Temporary Spur Stent System included:
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.
Enrollments ongoing in DEEPER REVEAL clinical trial
Patients have been successfully enrolled and treated in the DEEPER REVEAL investigational device exemption (IDE) clinical trial (NCT05358353) throughout the U.S. since November 2022.
Dr. Joseph M. Griffin, a Vascular Surgery specialist in Baton Rouge, Louisiana, shares a case report detailing a successful patient procedure using Reflow’s coraForce™ catheter.
Welcome Guenter Haines, Vice President of Sales, United States
Guenter joins the team at Reflow Medical with more than 20 years of experience in the healthcare industry at companies such as Boston Scientific, BIOTRONIK, and Cardiac Dimensions, where he held executive-level positions. His background in developing and leading sales organizations includes building award-winning teams and managing sales operations, business development and strategic planning.
Reflow has received CE (Conformité Européenne) Mark certification in the European Union for the Bare Temporary Spur Stent System for treating de novo or restenotic below-the-knee (BTK) lesions in the infrapopliteal arteries in conjunction with a commercially available drug-coated balloon (DCB).
