SAN CLEMENTE, Calif., May 20, 2026
Reflow Medical, Inc. has announced encouraging six-month clinical results from its DEEPER CORONARY first-in-human study evaluating the investigational Spur® Elute Sirolimus-Eluting Retrievable Stent System for the treatment of coronary in-stent restenosis (ISR). The data, presented at EuroPCR 2026 in Paris, France, demonstrated strong safety and efficacy outcomes, highlighting the growing potential of the company’s innovative Retrievable Scaffold Therapy (RST) platform for treating complex coronary artery disease. The latest findings position Reflow Medical among the emerging innovators developing next-generation cardiovascular devices aimed at improving long-term outcomes while reducing complications associated with permanent metallic implants.
DEEPER CORONARY Study Shows Strong Six-Month Results
The DEEPER CORONARY trial is a first-in-human pilot study designed to evaluate the short-term safety and clinical performance of the investigational coronary Spur Elute System in patients with coronary ISR, a condition where previously treated coronary arteries become narrowed again following stent implantation. According to the study results presented by Scott Harding, M.D., Director of the Cardiology Research Group at Wellington Hospital and principal investigator of the study, the investigational system achieved 100% freedom from major adverse cardiac events (MACE) and 100% freedom from all-cause mortality among the nine treated patients at six months.
The study also demonstrated meaningful symptomatic improvement in all treated patients, with participants experiencing a median improvement of three Canadian Cardiovascular Society (CCS) angina classes, reflecting substantial reduction in chest pain severity and improved quality of life. Investigators described the data as highly encouraging for both acute and mid-term safety outcomes and noted that the results support continued evaluation of the Spur Elute system as a novel treatment strategy for coronary artery disease and restenosis management.
Dr. Harding stated that the early findings reinforce the therapeutic potential of the retrievable sirolimus-eluting stent platform while supporting further clinical investigation across broader patient populations suffering from complex coronary disease.
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Innovative Retrievable Stent Technology Targets Restenosis
The investigational Spur Elute Sirolimus-Eluting Retrievable Stent System represents a differentiated approach to coronary intervention because it combines a self-expanding retrievable stent, integrated balloon technology, and a proprietary sirolimus drug coating designed to optimize drug delivery while avoiding permanent metallic implantation.
According to Reflow Medical, the system’s radially expandable spikes create microchannels within the vessel wall to enhance absorption of the antiproliferative sirolimus drug, which is intended to reduce excessive tissue growth and lower the risk of restenosis recurrence. The temporary scaffold simultaneously provides mechanical support to maintain arterial lumen diameter during treatment. Once therapy delivery is completed, the entire device is fully removed, leaving no permanent implant behind.
The company refers to this approach as Retrievable Scaffold Therapy (RST), a platform designed to combine the benefits of traditional drug-eluting stents with the advantages of temporary vascular support and enhanced drug penetration. Industry experts continue to identify bioresorbable and retrievable cardiovascular technologies as important next-generation innovations capable of reducing long-term complications associated with permanent coronary implants.
Isa Rizk, Chief Executive Officer and Co-Founder of Reflow Medical, stated that the six-month DEEPER CORONARY data represent an important milestone for the company’s expanding coronary program. He emphasized that the findings strengthen confidence in the clinical potential of the Spur Elute platform while supporting the company’s mission to advance innovative treatment options for patients suffering from complex cardiovascular disease.
Cardiovascular Innovation Continues Advancing
Coronary in-stent restenosis remains a major clinical challenge in interventional cardiology despite significant advances in drug-eluting stent technology over the past two decades. Physicians and device manufacturers continue searching for improved strategies capable of reducing repeat procedures, minimizing vessel injury, and improving long-term vessel healing.
The positive DEEPER CORONARY findings further reinforce the growing role of drug-coated technologies, temporary scaffold systems, and minimally invasive cardiovascular devices within modern cardiology. Reflow Medical’s broader product portfolio includes coronary and peripheral microcatheters, crossing catheters, and additional endovascular treatment technologies addressing complex vascular disease.
As cardiovascular device innovation continues accelerating globally, technologies that combine targeted drug delivery, temporary vascular support, and improved vessel healing are increasingly attracting scientific and commercial interest across the interventional cardiology sector.
Source: Reflow Medical press release
