US-based medical equipment manufacturer Reflow Medical has received the CE mark for its Bare temporary spur stent system to treat a type of Below-the-Knee (BtK) lesions.
The Bare temporary spur stent system is a unique clinical solution, known as Retrievable Stent Therapy (RST), which provides stent-like results while leaving no metal behind.
It is a self-expanding stent, designed with radial spikes to create channels in the vessel wall to enhance drug absorption and reduce recoil.
The system, together with a commercially available drug-coated balloon (DCB), is indicated for the treatment of restenotic lesions in the infrapopliteal arteries to enhance drug absorption.
Reflow Medical co-founder and CEO Isa Rizk said: “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 organisation to commercialise this breakthrough technology and serve the needs of physicians and their patients in countries accepting this certification.”
The treatment using the Bare temporary spur stent system, followed by DCB, is said to reduce clinically driven target lesion revascularisation (CD-TLR).
It would also improve wound healing, reduce recoil, and improve vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone.
Reflow Medical said its Bare temporary spur stent system was approved as a Class 2a medical device under the European Union (EU) Medical Device Regulation (MDR).
The EU MDR is a stringent process that requires manufacturers to provide substantial evidence supporting the performance and safety of the device.
DEEPER OUS clinical trial principal investigator Thomas Zeller said: “The device performance and clinical study data for patients suffering from CLTI has been quite impressive.”
DEEPER LIMUS clinical trial principal investigator Marianne Brodmann said: “We have found that the Spur allows us to treat patients with (BTK) disease using stent therapy, without the long-term risk of a stent implant.”
