Medical technology company CathWorks is seeking approval from the US Food & Drug Administration (FDA) for its FFRangio system, which delivers wire-free 3D FFR guidance needed to optimize PCI therapy decisions for every patient.
CathWorks submitted the system to the FDA for review and 510(k) market clearance.
The CathWorks system is still in development and has not yet been cleared by the FDA, nor is it available for sale within the US.
The FDA 510(k) submission was filed on 7 August after an early full enrollment of the FAST-FFR trial.
CathWorks CEO Jim Corbett said: “The FAME trials clearly demonstrated the clinical and economic value of FFR in PCI decision-making. We are confident that the CathWorks FFRangio System meets a real need for patients and physicians, and we expect the system to make non-invasive, wire-free FFR possible in coronary angiograms; reducing wire-related risks and costs.”
CathWorks expects to receive 510(k) market clearance by the end of this year. As CathWork’s system is compatible with majority of coronary angiogram platforms and a clear CPT code, it expects the system will help benefitting physicians and their patients very soon.
On 15 August, the company announced its fast FFR trial enrollment had been completed early. Enrollment of the trial began in September last year and 382 subjects were recruited.
In July, CathWorks received CPT code 0523T for non-invasive, 3D FFRangio. Issue of the code is considered to be a major step to help physicians objectively and cost-efficiently determine if PCI is indicated and revascularization has occurred in every coronary angiography procedure.
The CPT code 0523T enables healthcare providers using the FFRangio to be reimbursed for Intraprocedural coronary fractional flow reserve (FFR) with 3D functional mapping of color-coded FFR values for the entire coronary tree, derived from coronary angiogram data that allow real-time review and interpretation of possible atherosclerotic stenosis(es) intervention.