Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, March 04 2021 - 10:00
MedAlliance Receives Fourth FDA Breakthrough Device Designation for Sirolimus Drug-Eluting Balloon in Treatment of De Novo Coronary Lesions
NYON, Switzerland, March 4, 2021 /PRNewswire-AsiaNet/ --

MedAlliance, the first drug-eluting balloon (DEB) company in the world to 
receive US Food and Drug Administration (FDA) Breakthrough Device Designation 
Status for a sirolimus DEB, has now been awarded breakthrough status for 
SELUTION SLR(TM), its sustained limus release DEB catheter, in the treatment of 
atherosclerotic lesions in native coronary arteries. This is the fourth 
breakthrough designation awarded to MedAlliance for its sirolimus DEB, 
following coronary in-stent restenosis, peripheral below-the-knee and 
AV-Fistula indications.

According to the FDA, the SELUTION SLR 014 DEB Breakthrough Designation is for 
improving luminal diameter in patients with atherosclerotic lesions in native 

"MedAlliance is honoured to have our sirolimus DEB selected for the FDA's 
Breakthrough Device Program for a fourth time. This may provide US patients 
faster access to our novel 90 day sustained sirolimus release technology, with 
the potential to provide safer and more effective treatment," said Jeffrey B. 
Jump, Chairman and CEO of MedAlliance. "This Designation, combined with the 
previous coronary ISR Breakthrough Designation, will give US cardiologists 
exciting new tools to fight coronary disease."

The FDA Breakthrough Device Program is intended to help patients receive more 
timely access to breakthrough technologies that have the potential to provide 
more effective treatment or diagnosis for life-threatening or irreversibly 
debilitating diseases or conditions. Under the program, the FDA will provide 
MedAlliance with priority review and interactive communication regarding device 
development and clinical trial protocols, through to commercialization 

The goal of the Breakthrough Devices Program is to provide patients and 
healthcare providers with timely access to these medical devices by speeding up 
their development, assessment, and review, while preserving the statutory 
standards for premarket approval, 510(k) clearance, and de novo marketing 
authorization, consistent with the Agency's mission to protect and promote 
public health. 

SELUTION SLR's technology involves unique MicroReservoirs made from 
biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These 
MicroReservoirs provide controlled and sustained release of the drug. Extended 
release of sirolimus from stents has been proven highly efficacious in both 
coronary and peripheral vasculatures. MedAlliance's proprietary CAT(TM) (Cell 
Adherent Technology) enables the MicroReservoirs to be coated onto balloons and 
adhere to the vessel lumen when delivered via an angioplasty balloon.

About MedAlliance

Founded in 2008, MedAlliance is a privately-owned medical technology company. 
It is headquartered in Switzerland, with facilities in Irvine, California; 
Glasgow, UK; and Singapore. MedAlliance specializes in the development of 
ground-breaking technology and commercialization of advanced drug device 
combination products for the treatment of coronary and peripheral artery 
disease. For further information visit:

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Media Contact: 
Richard Kenyon 
+44 (0)7831 569940

Source: MedAlliance