Reflow Medical has announced the completion of enrolment in the DEEPER CORONARY study.
This pilot study evaluates the Spur Elute coronary sirolimus-eluting retrievable scaffold system as a primary treatment for in-stent restenosis (ISR) of the coronary arteries.
Spur Elute is 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 designed 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 rehospitalisation,” said William Lombardi (UW Medicine Heart Institute, Seattle, USA), a member of the Reflow Medical scientific advisory board. “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 enrolment 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 maximise luminal gain and reduce restenosis. The system is then fully removed without leaving a permanent metallic implant behind.
Scott Harding (Wellington Hospital, Wellington, New Zealand), principal investigator of the DEEPER CORONARY trial, commented: “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.”
Isa Rizk, chief executive officer and co-founder of Reflow Medical, added: “The completion of enrolment 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. We are proud of our team and partners for making this possible and look forward to sharing the first clinical results at TCT 2025.”
Late-breaking data from DEEPER CORONARY will be presented by Harding at the Cardiovascular Research Foundation’s TCT 2025 (25–28 October, San Francisco, USA) in the innovation category. Highlights will include the primary endpoint, treatment of the target lesion with the investigational device without the occurrence of in-hospital major adverse cardiovascular events (MACE; defined as all-cause death, myocardial infarction, and any clinically driven target lesion revascularisation), as well as secondary endpoints of lesion success and safety data through 30 days.
