02/10/2019
ThermoTek’s VascuTherm chosen to Participate in the FDA’s Opioid Innovation Challenge. 🤩
Link: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cdrh/cdrhinnovation/ucm609082.htm
FLOWER MOUND, TX - As part of the FDA’s ongoing commitment to address the opioid crisis, the FDA’s Center for Devices and Radiological Health (CDRH) launched Innovation Challenge in May 2018. The challenge was intended to spur the development of medical devices, including digital health technologies and diagnostic tests, that could provide new solutions to detecting, treating and preventing addiction, addressing diversion and treating pain. This effort resulted in ThermoTek being chosen specifically by the FDA to participate in the Opioid Innovation Challenge.
The goal was to provide additional incentives for medical device developers to invest in products that can address the addiction crisis and advance the development of innovative, safe and effective technologies. The FDA received more than 250 applications from medical device developers.
In each proposal, applicants described the novelty of the medical device or concept; the development plan for the medical device; the team who would be responsible for developing the device; the anticipated benefit of the device when used by patients; and, the impact on public health as compared to other available alternatives. Medical devices at any stage of development were eligible for the challenge. Feasibility and the potential impact of the FDA’s participation in development to expedite marketing of the device were also factors considered when reviewing the submissions.
Based on these criteria, and after reviewing over 250 submissions from therapeutic and diagnostic medical device manufacturers, ThermoTek was selected by the FDA as one of only eight chosen to participate. As part of the FDA’s Innovation Challenge, ThermoTek’s VascuTherm is being evaluated as the only thermal/compression device within the Innovation Challenge intended to treat opioid use disorder or treat pain.
“We believe this effort will provide improved awareness of the benefits of the therapies provided by ThermoTek’s VascuTherm devices. There is still a lot of work to be done in this effort but we hope that through working with the FDA we can expand the VascuTherm’s recognized indications for use; which will result in broader acceptance and better insurance coverage.” said Sam McSpadden, CEO of ThermoTek.
Throughout the Breakthrough Device designation process with the FDA, ThermoTek’s VascuTherm will receive increased interaction with CDRH experts, guidance for clinical trial development plans, and expedited review. Breakthrough Device designation will be granted to those devices selected in the Challenge that meet the statutory criteria for designation. Throughout the process, ThermoTek will work with the FDA to ensure that patient safety is our number one priority and we’ll still be held to the FDA’s gold standard and required to meet the applicable standard of safety and effectiveness.
