Enrollment in Spur Elute DEEPER CORONARY Study is Complete

Reflow Medical Inc. has completed enrollment in the DEEPER CORONARY study, designed to evaluate the Spur Elute Coronary Sirolimus-Eluting Retrievable Scaffold System as a primary treatment for in-stent restenosis (ISR) of the coronary arteries.

“The completion of enrollment in the DEEPER CORONARY study is an important milestone for patients suffering from coronary in-stent restenosis, and for the physicians dedicated to treating this challenging condition,” Reflow Medical Co-Founder/CEO Isa Rizk stated. “We are proud of our team and partners for making this possible.”

Spur Elute is touted by Reflow Medical as the first and only retrievable self-expanding scaffold with radially expandable spikes, combined with an integrated balloon, both of which are drug coated. It is made to treat patients with coronary ISR by dilating and delivering a sirolimus drug formulation unique to Reflow Medical.

“ISR is an inherent risk of permanent stent implantation, leading to substantial healthcare costs, and is often associated with increased risks of death and rehospitalization,” said William Lombardi, M.D., interventional cardiologist and director of the Complex Coronary Program at UW Medicine Heart Institute in Seattle, and a Reflow Medical Scientific Advisory Board member. “It is great to collaborate with a company committed to addressing coronary challenges with innovations such as the Spur Elute.”

The DEEPER CORONARY first-in-human study successfully completed enrollment with nine subjects treated. Participants will continue follow up for one year after the procedure.

Known as Retrievable Scaffold Therapy (RST), the Spur Elute spikes create channels to increase uptake of the antiproliferative drug into the vessel wall, while dilating the arterial lumen to maximize luminal gain and reduce restenosis. The system is then fully removed without leaving a permanent metallic implant behind.

“The preliminary results of the trial are encouraging, highlighting the potential of Spur Elute to address the challenges of ISR. It is designed to reduce neointimal hyperplasia and recoil of the hyperplastic neointima without leaving another stent behind,” commented Scott Harding, M.D., director of the Cardiology Research Group at Wellington Hospital (Wellington, New Zealand) and DEEPER CORONARY trial principal investigator.

Reflow Medical is a global company that partners with physicians to develop technologies addressing unmet clinical needs in the endovascular treatment of complex cardiovascular disease. The company’s portfolio includes coronary and peripheral microcatheters, crossing catheters, and a revolutionary device enabling Retrievable Scaffold Therapy (RST). The coronary CoraCatheters line is approved by the U.S. Food and Drug Administration (FDA). The peripheral product line includes Wingman, Spex, Spex LP, and Spur, which have FDA clearance and CE Mark registration. Reflow Medical is headquartered in San Clemente, Calif.