Reflow Medical Enrolls First Patients in Pilot Study of Coronary Sirolimus-Eluting Retrievable Scaffold System (Spur Elute)
July 01 2024 - 7:02PM
Business Wire
Reflow Medical, Inc., a developer of innovative devices focused
on cardiovascular disease, announces the first patient enrollments
in “A pilot study of the Drug-Eluting Coronary Spur™
StEnt as a Primary trEatment for in-stent
Restenosis (ISR) of the CORONARY arteries” (DEEPER
CORONARY, NCT06117150). ISR is a common clinical problem that can
generate significant health care costs and is often associated with
an increased risk of death and rehospitalization. Known as the
Coronary Sirolimus-Eluting Retrievable Scaffold System, or “Spur
Elute,” this unique clinical solution is intended to treat patients
with coronary ISR by transferring a proprietary sirolimus drug
formulation to the diseased lesion without leaving a permanent
metallic implant behind. The study is approved to enroll a total of
10 patients at up to three centers in New Zealand.
Principal Investigator Prof. Scott Harding, M.D., is an
interventional cardiologist specializing in the treatment of
complex coronary disease at Wellington Hospital in Wellington, New
Zealand. He shared his experience with the Spur Elute, saying,
“It’s exciting to take part in the study of this novel platform,
which has the potential to successfully treat patients suffering
from in-stent restenosis.”
William Lombardi, M.D., and Kathleen E. Kearney, M.D.,
interventional cardiologists at the UW Medicine Heart Institute in
Seattle, Washington, were in attendance at the first enrollment.
“Being able to deliver anti-proliferative drugs while maintaining
blood flow can be a crucial element for treating ISR patients,”
said Dr. Lombardi, who is the Director of the Complex Coronary
Program at the Institute.
The Spur Elute is a novel device whose Retrievable Scaffold
Therapy (RST) creates channels to increase uptake of
antiproliferative drugs, while dilating the arterial lumen to
maximize gain during the procedure. The system is then removed,
without leaving anything behind.
“These enrollments take us one step closer to enabling
physicians to utilize the Spur platform for treating patients with
cardiovascular disease, and ISR in particular,” said Isa Rizk, CEO
and Co-Founder of Reflow Medical, Inc. “We are so proud of the
entire team and grateful to our external CRO, Mobius Medical, for
reaching this milestone.” The pilot study of the Spur Elute for
accessing and treating ISR follows last year’s successful
introduction of the Reflow coraCatheters™ line for complex
percutaneous coronary interventions (PCI).
About Reflow Medical, Inc.
Reflow Medical, Inc. focuses on empowering physicians through
the design and development of innovative and effective technologies
for cardiovascular disease. The Reflow portfolio includes products
designed for use in treating cardiovascular disease in the coronary
and peripheral vasculature.
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Jennifer Carlyle jcarlyle@reflowmedical.com 949-481-0399