US-based Cordis, a leading interventional cardiovascular and endovascular technology developer and manufacturer, announced that it has acquired Swiss medical technology company MedAlliance for $1.135B (approximately €1.08B).
MedAlliance’s SELUTION SLR (Sustained Limus Release) programme, which includes a sustained sirolimus drug-eluting balloon (DEB), has been added as a new flagship product line that complements Cordis’ offerings. In return, Cordis will apply its sales, marketing, and distribution expertise to benefit MedAlliance’s customers.
Cordis’ customers will also gain from MedAlliance’s comprehensive clinical research and publications, especially those suffering from coronary and peripheral disease. These efforts will further strengthen Cordis’ commitment to delivering innovative patient solutions.
Shar Matin, Cordis CEO, says, “As a newly independent company, we are beyond proud to further our legacy of innovation and market disruption with MedAlliance and the first MicroReservoir sirolimus drug-eluting balloon, SELUTION SLR.”.
More about SELUTION SLR
SELUTION SLR is a new generation of a drug-eluting balloon designed to be as safe and effective as the best drug-eluting stents but without leaving any permanent device in the body. It uses a proprietary technology to deliver a sustained dose of the drug sirolimus to the vessel wall.
A drug-eluting balloon is a “balloon” coated with a drug that helps prevent scar tissue formation in blood vessels. The balloon is inflated inside the blood vessel to widen it and deliver the drug.
This innovation allows controlled and sustained drug release for up to 90 days. It is available in a wide range of sizes to treat coronary and peripheral artery disease, making it a valuable addition to Cordis’ portfolio.
It is now commercially available in Europe, Asia, the Middle East, the Americas (excluding the U.S.), and other countries where the approval is recognised. So far, more than 40,000 units have been used to treat patients during routine clinical practice or coronary clinical trials.
“I want to thank our entire MedAlliance team – including physicians, distributors and clinical patients – who have succeeded in disrupting the coronary and peripheral markets to provide a safe and effective new technology,” says Jeffrey B. Jump, founder, chairman and CEO of MedAlliance.
“The arsenal of SELUTION SLR DEB clinical data is designed to change medical practice and improve patient outcomes,” adds Jump.
Approvals and studies
SELUTION SLR received CE Mark Approval for treating peripheral artery disease in February 2020 and coronary artery disease in May 2020. Three FDA studies involving SELUTION SLR are currently under work, with a fourth study on coronary de novo artery disease planned to start soon.
The latter is expected to complement the ongoing European trial with over 1,700 patients enrolled, halfway towards the planned 3,326. This trial could change medical practice by showing that drug-eluting balloons are a safe and effective alternative to permanent metallic stents for treating de novo coronary lesions.
This innovation made MedAlliance the first drug-eluting balloon company to receive FDA Breakthrough Designation status.
“We are excited to report on the positive SELUTION SLR data to date, with first-hand experience of the impressive clinical outcomes from patients treated with SELUTION SLR in Japan, India, Europe, and South America,” says George Adams, Director of Cardiovascular and Peripheral Vascular Research at Rex Hospital Inc. in North Carolina, United States.
“We are now leading the effort to emulate these results in the United States,” adds Adams.