Jun 24, 2019   SOURCE: PR NewsWire

Update on FDA Panel Meeting on Paclitaxel Coated Products

PLEASANTON, Calif., June 24, 2019 /PRNewswire/ -- QT Vascular Ltd. (the "Company"), is a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease.

The United States Food and Drug Administration ("FDA") Circulatory System Devices Panel of the Medical Devices Advisory Committee on paclitaxel-coated devices in patients with peripheral artery disease (the "Panel") took place on 19 and 20 June 2019.

The Panel discussed the benefits of paclitaxel-coated devices relative to the mortality signal identified in the 15 March 2019 FDA letter. The Panel presentations and discussions included a broad range of topics related to paclitaxel drug coated balloons ("DCB") and drug-eluting stents. Quality of life benefits including lower re-intervention rates were acknowledged by the Panel members with a view that paclitaxel-coated devices should remain on the market. Panel members recommended that product labels shall include the late mortality signal information, while additional long-term data should be collected.

The Company is currently enrolling patients in the Chocolate Touch® United States IDE ("US IDE") clinical trial, a randomized trial intended to evaluate the safety and effectiveness of the Company's Chocolate Touch® paclitaxel-coated balloon for the treatment of subjects with disease in the superficial femoral and popliteal arteries in the legs. The Company plans to continue with the enrolment of patients in its US IDE clinical trial.

Chocolate Touch® is the only DCB that incorporates a next generation drug delivery platform that protects the artery from torsional stresses and minimizes dissections. All DCBs that were discussed at the Panel are based on Plain Old Balloon Angioplasty (POBA) catheters.

More information can be found at the FDA website. For convenience, below are links to the video recording of the Panel:

19 June: http://fda.yorkcast.com/webcast/Play/2bd79244c1b34fe8b1e794f99c8f04061d
20 June: http://fda.yorkcast.com/webcast/Play/455ae494725744c0ad0bfe24288a17bf1d

The Company will continue to update shareholders on SGXNet as and when there are any material developments on the aforementioned.

View original content:http://www.prnewswire.com/news-releases/update-on-fda-panel-meeting-on-paclitaxel-coated-products-300873674.html

SOURCE QT Vascular Ltd.