A stent system designed by Reflow Medical to treat de novo or restenotic lesions in the infrapopliteal arteries has been awarded a CE mark.
US-based cardiovascular device specialist, Reflow Medical, has confirmed that its stenting system, known as the Bare Temporary Spur Stent System, was granted the CE Mark following a clinical trial that saw the device help to heal long-lasting wounds in patients suffering from conditions such as peripheral artery disease, as well as critical limb-threatening ischemia.
Known as Retrievable Stent Therapy (RSP), the stent is self-expanding and equipped with spikes along its outer edges which create channels in the blood vessels of patients to enhance drug absorption and recoil, after which it is removed using a commercially available drug-coated balloon.
The announcement follows the company’s DEEPER OUS clinical trial (NCT03807531), a 107-patient, prospective, non-randomized, multicenter, single-arm study designed to evaluate the safety and efficacy of Spur, in combination with a paclitaxel-coated balloon, to treat patients living with below-the-knee arterial diseases.
Principal investigator for the trial, Thomas Zeller, said: “We observed a statistically significant reduction in Rutherford class scores and wound healing at six months, with sustained improvement in these clinical outcomes through 12 months. These results confirm the promise of the Temporary Spur Stent for treating patients suffering from peripheral artery disease and critical limb-threatening ischemia (CLTI).”
In 2023 ReFlow Medical presented early results from the study, that found an 86% primary patency rate at six months. Patency describes the lack of obstruction of blood vessels, indicating that the primary effectiveness endpoint was met. The CE mark also comes as the company was able to secure market authorisation in Japan for its Wingman Cross Chronic Total Occlusions Catheter.
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GlobalData’s Medical Device Intelligence centre estimates that throughout 2023 the total sales for the peripheral vascular stent market is estimated to be around $3bn.
Isa Rizk, Reflow Medical’s CEO, added: “Earning the CE Mark is a huge milestone for the company. It enables us to offer a clinically validated solution to an unmet need in a major disease area. Our next goal is to expand our organization to commercialize this breakthrough technology and serve the needs of physicians and their patients in countries accepting this certification.”