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, its sustained limus release DEB catheter, in the treatment of AV fistula indications. This is the third breakthrough designation awarded to MedAlliance for its sirolimus DEB, following coronary in-stent restenosis and peripheral below-the-knee indications.
According to a press release, SELUTION’s technology involves unique micro-reservoirs made from biodegradable polymer intermixed with the antirestenotic drug sirolimus. These micro-reservoirs provide controlled and sustained release of the drug. Extended release of sirolimus from stents has been demonstrated highly efficacious in both coronary and peripheral vasculatures. MedAlliance’s proprietary CAT (cell adherent technology) enables the micro-reservoirs to be coated onto balloons and adhered to the vessel lumen when delivered via an angioplasty balloon.
“MedAlliance is honored to have our sirolimus DEB selected for the FDA’s breakthrough device programme for a third time. This may provide US patients faster access to a new technology with the potential to provide safer and more effective treatment,” said Jeffrey B Jump, chairman and CEO of MedAlliance.
The FDA breakthrough device programme 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 programme, the FDA will provide MedAlliance with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialisation decisions.
The goal of the breakthrough devices programme 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 authorisation, consistent with the agency’s mission to protect and promote public health.
Two-year clinical follow-up data on the company’s SFA (superficial femoral artery) sirolimus DEB and six-months follow up data on the coronary de novo and in-stent restenosis DEB were presented at TCT and VIVA last year.
