Michael Barbella, Managing Editor03.21.24
Reflow Medical Inc. has received CE Mark certification in the European Union for the Bare Temporary Spur Stent System. The device is intended to treat de novo or restenotic lesions in the infrapopliteal arteries with a commercially available drug-coated balloon (DCB) to enhance drug absorption.
“The device performance and clinical study data for patients suffering from CLTI has been quite impressive,” said Professor Thomas Zeller, M.D., chief of the Department of Angiology at University Heart Center Freiburg in Bad Krozingen, Germany, and principal investigator in the DEEPER OUS clinical trial.
Chronic limb-threatening ischemia (CLTI) increases the risk of mortality, amputation, and impaired quality of life. The Bare Temporary Spur Stent System, followed by drug-coated balloon treatment, reduces clinically driven target lesion revascularization (CD-TLR), improves wound healing, reduces recoil, and improves vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone.
“We have found the Spur allows us to treat patients with (BTK) disease using stent therapy, without the long-term risk of a stent implant,” stated Marianne Brodmann, M.D., a professor and vascular specialist with the Division of Angiology, Medical University Graz in Graz, Austria, and principal investigator for the DEEPER LIMUS clinical trial to evaluate the Bare Temporary Spur Stent System.
The Bare Temporary Spur Stent System is intended to provide stent-like results while leaving no metal behind. Known as Retrievable Stent Therapy, or RST, the self-expanding stent is designed with radial spikes for creating channels in the vessel wall to enhance drug absorption and reduce recoil. The stent is then recaptured, removed, and treated with a commercially available drug-coated balloon.
“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,” Reflow Medical Co-Founder/CEO Isa Rizk said. “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.”
The Reflow Medical Bare Temporary Spur Stent System was granted certification as a Class IIa medical device under the European Union Medical Device Regulation.
Established in 2011, Reflow Medical Inc. is a private company focused on empowering physicians through the design and development of technologies for treating cardiovascular disease.
“The device performance and clinical study data for patients suffering from CLTI has been quite impressive,” said Professor Thomas Zeller, M.D., chief of the Department of Angiology at University Heart Center Freiburg in Bad Krozingen, Germany, and principal investigator in the DEEPER OUS clinical trial.
Chronic limb-threatening ischemia (CLTI) increases the risk of mortality, amputation, and impaired quality of life. The Bare Temporary Spur Stent System, followed by drug-coated balloon treatment, reduces clinically driven target lesion revascularization (CD-TLR), improves wound healing, reduces recoil, and improves vessel patency through one year, compared to historical treatment outcomes with plain balloon angioplasty or a DCB alone.
“We have found the Spur allows us to treat patients with (BTK) disease using stent therapy, without the long-term risk of a stent implant,” stated Marianne Brodmann, M.D., a professor and vascular specialist with the Division of Angiology, Medical University Graz in Graz, Austria, and principal investigator for the DEEPER LIMUS clinical trial to evaluate the Bare Temporary Spur Stent System.
The Bare Temporary Spur Stent System is intended to provide stent-like results while leaving no metal behind. Known as Retrievable Stent Therapy, or RST, the self-expanding stent is designed with radial spikes for creating channels in the vessel wall to enhance drug absorption and reduce recoil. The stent is then recaptured, removed, and treated with a commercially available drug-coated balloon.
“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,” Reflow Medical Co-Founder/CEO Isa Rizk said. “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.”
The Reflow Medical Bare Temporary Spur Stent System was granted certification as a Class IIa medical device under the European Union Medical Device Regulation.
Established in 2011, Reflow Medical Inc. is a private company focused on empowering physicians through the design and development of technologies for treating cardiovascular disease.