MedAlliance
Geneva, March 15, 2023 (Reuters) /PRNewswire/
MedAlliance announced the enrollment of more than 1,000 patients in its landmark SELUTION DeNovo heart attack study. Recruitment is now a third of the way towards the target of 3,326 patients. SELUTION DeNovo compares treatment strategy using a novel drug-eluting balloon [DEB-SELUTION] compared to a limus drug-eluting stent [DES].
SELUTION DeNovo is the largest DEB study ever initiated with up to 70 participating sites in 15 countries. Patients are randomly selected prior to each vessel preparation to reflect current medical practice and to reduce bias. The aim of the study is to demonstrate no inferiority at one and five years and to demonstrate superiority in target vessel failure (TVF) at five years.
This study aims to transform medical practice, as most again -Heart attack lesions are currently treated with an indwelling metallic stent. SELUTION SLR consists of an angioplasty balloon coated with MicroReservoirs containing a mixture of biodegradable polymer and the antirestenotic drug “Sirolimus”. These MicroReservoirs provide controlled and sustained release of the drug for more than 90 days, similar to DES, but without leaving behind a metal framework, which is associated with a complication rate of 2% per year.
“This is an important milestone for the SELUTION DeNovo study as it is now the largest DEB study ever conducted,” said Co-Principal Investigator Professor Christian Spaulding, Department of Cardiology, European Hospital Georges Pompidou, Assistance Publique Hôpitaux de Paris and Paris Cité University, Paris, France. “The study will be carried out in a population in which anyone can participate. It does not only refer to coronary artery disease. The results will have a major impact on clinical practice.”
“This study has the potential to transform medical practice not only in Europe but also in the US, China and Japan, which will benefit patients around the world,” added Jeffrey B. Jump, Chairman and CEO of MedAlliance. “We are currently enrolling US patients in our IDE and BTK coronary ISR studies in the US and Europe.”
SELUTION SLR received CE approval for the treatment of coronary artery disease in May 2020. MedAlliance was the first drug-eluting balloon company to receive breakthrough designation from the FDA. In addition to the BTK and superficial femoral artery (SFA) indications for which the Company received IDE approval from the FDA in May 2022 and August 2022, MedAlliance received IDE approval for in October 2022 coronary in-stent restenosis (ISR), and on January 6, 2023 the approval for the novo- coronary artery lesions. This will complement the extensive experience the company has already gained with the SELUTION DeNovo study in Europe.
DEB’s unique MedAlliance technology are MicroReservoirs containing a mixture of biodegradable polymer and the anti-restenosis drug Sirolimus. These are applied as a coating to the surface of an angioplasty balloon. These MicroReservoirs provide a controlled and sustained release of drug for up to 90 days MedAlliance’s proprietary CAT™ (Cell Adhesive Technology) allows the MicroReservoirs to be coated onto balloons and adhere efficiently to the vessel lumen when delivered via the balloon’s expansion .
SELUTION SLR is commercially available in Europe, Asia, Middle East, North and South America (excluding US) and most other countries where the CE Mark is recognized. More than 10,000 units have been used for patient treatments in routine clinical practice or as part of coronary clinical studies.
About MedAlliance
Media contact:
Richard Kenyon,
[email protected]+44 7831 569940
MedAlliance is a medical technology company that announced a staged acquisition of Cordis in October 2022. Headquartered in Nyon, Switzerland, MedAlliance specializes in the development of breakthrough technologies and the commercialization of advanced drug combination products for the treatment of coronary and peripheral artery disease. You can find more information on: www.medalliance.com
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