MedAlliance has now been granted FDA Breakthrough Device Designation status for its Selution sustained limus release (SLR) sirolimus-eluting balloon for an arteriovenous fistulae indication. The company has previously received similar status for the coronary in-stent restenosis and peripheral below-the-knee indications of the balloon. According to a press release, Selution’s technology involves unique micro-reservoirs made from biodegradable polymer intermixed with the anti-restenotic drug sirolimus.
The press release states that these micro-reservoirs provide controlled and sustained release of the drug, adding that 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. Jeffrey B Jump, chairman and CEO of MedAlliance, comments: “MedAlliance is honoured to have our sirolimus drug-eluting balloon 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.”
Prior to being granted FDA Breakthrough Device Designation status for the arteriovenous fistulae indication, MedAlliance announced the completion of patient enrolment in the PRESTIGE Below-the-Knee (BTK) clinical trial. A press release reports that the objective of this clinical investigation is to evaluate the six-month safety and performance outcomes of Selution SLR for the treatment of long tibial occlusive lesions (TASC C & D) in patients with critical limb ischaemia.
The press release explains that PRESTIGE is a prospective, single-centre, physician-initiated clinical study, being run at Singapore General Hospital by Chong Tze Tec and Tang Tjun Yip. Twenty-two patients have now been enrolled. Clinical follow-up will be at one, three, six and 12 months.
Tec comments: “The initial performance of Selution SLR has been very encouraging. We have observed good blood flow in the amputation segment and some cases of fast wound healing. The device is also easy to track and deliver. We are eagerly awaiting the study’s follow-up data”.