Swiss medical technology firm MedAlliance has received FDA investigational device exemption (IDE) approval for its SELUTION SLR drug-eluting balloon (DEB) device.
The SELUTION SLR (Sustained Limus Release) is a new sirolimus-eluting balloon which provides a controlled sustained drug release (DES).
According to the firm, the device was also the first DEB (Drug Eluting Balloon) to receive FDA “breakthrough device designation” for below-the-knee (BTK) indications in peripheral artery disease on 4 March 2019 and again on 25 September 2019.
The technology used in the SELUTION SLR consists of MicroReservoirs including biodegradable polymer coupled with the anti-restenotic medication sirolimus.
The medicine is released in regulated and sustained Limus Release (SLR) in these MicroReservoirs.
When delivered through an angioplasty balloon, MedAlliance’s CATTM (Cell Adherent Technology) allows the MicroReservoirs to be coated onto balloons and stuck to the vascular lumen.
MedAlliance chairman and CEO Jeffrey Jump said: “This is a major milestone for MedAlliance.
“We have been able to successfully complete the bench and pre-clinical testing required by the FDA and are ready to begin enrolling US patients in a clinical study to support submission for FDA PMA approval.
“We are delighted that US patients may also benefit from this breakthrough technology.”
The firm will begin recruiting patients in the SELUTION4BTK Below-the-Knee (BTK) IDE Randomized Clinical Trial (RCT) immediately outside of the US and early this summer at US facilities.
In February 2020, SELUTION SLR received CE Mark approval for the treatment of peripheral artery disease.
The device demonstrated promising results in the treatment of patients with chronic limb-threatening ischemia (CLTI) and below-the-knee artery disease.
MedAlliance has moved forward with the design of the SELUTION4BTK RCT to further study the safety and efficacy of the device and prepare for US FDA approval based on early positive evidence following the use of SELUTION SLR in the treatment of BTK disease.
SELUTION SLR is available in Europe and other countries that recognise the CE mark.
