MedAlliance has announced the enrollment of the first patient in its study of SELUTION SLR ™ 014 DEB  for the treatment of intra-stent restenosis (ISR). It is the first drug eluting balloon (DEB) accepted by the FDA as part of its "capital discovery support program". SELUTION SLR ( Sustained Limus Release ) is a new sirolimus-eluting balloon that provides sustained and controlled drug release, similar to that of a drug-eluting stent (DES).

The objective of this prospective, randomized, single-blind, multicenter study is to demonstrate the safety and efficacy of SELUTION SLR in the treatment of SRI with drug-eluting stents or bare metal stents (BMS). ). The study will support the FDA's request for approval.

“This first patient was treated with the experimental device after suffering from an ISR DES. We are very happy to be able to offer our patients this promising new technology ”, commented Professor Pascal Vranckx from Hartcentrum Hasselt, in Belgium. “We are delighted to participate in a study that validates this new technology for the treatment of SRI. SELUTION SLR may offer an additional treatment option to these patients. We look forward to the results of this study. "

Up to 418 people will be recruited to participate in this study, at nearly 60 sites in the United States and Europe . These human subjects must have a BMS or an ISR DES involving a native coronary artery which has a reference diameter of the vessel (RVD) of between 2.00 and 4.50 mm in order to be enrolled. Subjects will be randomized to receive either SELUTION SLR or standard therapy (SOC) - a control group with current DES or balloon angioplasty without drug elution.

The main criterion for evaluating the effectiveness of the study is failure attributable to the target lesion (TLF), which is defined as all deaths from cardiac causes; myocardial infarction due to the target vessel; or the revascularization of the target lesions (TLR) clinically provoked at 12 months.

The subjects will be followed at one month, six months, twelve months and then annually for five years.

"This is a particularly important study for MedAlliance," said Chairman and CEO Jeffrey B. Jump. "No coronary drug eluting balloon has yet been approved in the United States, where ISR currently accounts for 11% of all stent implantations. We are pleased to launch this revolutionary technology to help patients around the world. "

The principal investigator for this study is Donald Cutlip , Professor of Medicine at Harvard Medical School and Medical Director of the Baim Institute for Clinical Research. Professor Cutlip participated in the design of the study in consultation with the Institute.

The SELUTION SLR technology involves unique microreservoirs made from biodegradable polymer mixed with sirolimus, a drug against restenosis. These microreservoirs allow a prolonged release of limus (SLR) which is done under control. Prolonged release of sirolimus from stents has been shown to be very effective for the coronary and peripheral vessels. MedAlliance CAT ™ patented technology ( Cell Adherent Technology ) allows microreservoirs to be applied to balloons and to adhere to vascular lumen when administered through an angioplasty balloon.

SELUTION SLR obtained CE marking for the treatment of peripheral arterial diseases in February 2020 and for the treatment of coronary heart disease in May 2020. The product is now available in Europe and in all other countries where the CE marking is recognized. The global market for DEB is estimated at $ 2 billion.

About MedAlliance

MedAlliance is a private medical technology company. Based in Switzerland, it has facilities in Irvine , California; in Glasgow , the UK and Singapore. MedAlliance specializes in the development of revolutionary technologies and the marketing of cutting-edge products that combine medical devices and drugs to treat coronary artery disease and peripheral arteries. For more information, please visit: http://medalliance.com/

Media contact:
Richard Kenyon
rkenyon@medalliance.com
+ 44-7831-569940

 

Source: prnewswire.com

Report Abuse