On November 5, 2024, the VIVA Foundation reported on presentations at the VIVA25 conference, including two-year results of the DEEPER OUS clinical trial for the Reflow Medical Spur® Peripheral Retrievable Scaffold System.
Excerpt from the Nov. 5, 2024 press release from the VIVA Foundation
Retrievable Scaffold Therapy in Combination with a Paclitaxel-Coated Balloon: Two-Year Results of the DEEPER OUS Trial
Presented by Thomas Zeller, MD at VIVA24 on behalf of Dr. Michael Lichtenberg and the DEEPER OUS investigators: Retrievable Scaffold Therapy in Combination with a Paclitaxel-Coated Balloon: Two-Year Results of the DEEPER OUS Trial.
DEEPER OUS is a prospective, nonrandomized, multicenter, single-arm trial taking place in New Zealand, Germany, and Switzerland. The purpose of this trial is to evaluate the safety and efficacy of a novel device, the Spur Peripheral Retrievable Scaffold System (Reflow Medical, Inc.), in conjunction with a commercially available drug-coated balloon (DCB) in patients with symptomatic infrapopliteal arterial disease.
In-person follow-up occurred at 1, 3, 6, and 12 months postprocedure, with follow-up via telephone call annually out to 5 years.
The primary efficacy endpoint is primary patency of treated lesion sites by duplex ultrasound in patients free from clinically driven target lesion revascularization (CD-TLR) at 6 months. The primary safety endpoint is freedom from device- and procedure-related death through 30 days postprocedure. Secondary endpoints include safety-related and clinical outcome measures.
Lesion characteristics showed an average treated length of 92.7 ± 36.63 mm, and the most used Spur size was 3 X 60 mm, with an average reference vessel diameter of 3.1 ± 0.48 mm. Approximately 60% of vessels were mildly calcified, with the most common TASC classification being class B (37.2%, 51/106). The primary endpoints of primary patency at 6 months and freedom from perioperative death at 30 days were met and previously reported.
At 24 months, the secondary safety endpoint of freedom from major amputation of the target limb was met in 98.8% (79/80), all-cause mortality was 14% (15/107), and freedom from CD-TLR was 83.5% (71/85).
The Spur System is safe and effective for the treatment of infrapopliteal arterial disease when used in conjunction with a commercially available DCB.
Read the complete press release.