30-Day Follow-Up Results of the First in Human (FIH) Clinical Test Series of the FastSeal® Bioabsorbable Vascular Access Closure System – 100% Success Rate, Including Patients with Challenging Anatomy and Vessel Condition.
The company is pleased to announce that the 30-Day follow-up results for the Phase I FIH clinicals have been perfect, as confirmed by doppler and ultrasound evaluation. The evaluation confirmed normal vessel healing, with complete absorption of the FastSeal® sealing element. During the follow-up, no adverse events were observed - no hematoma, pseudoaneurysm or fistulas were present in any of the patients. All patients were asymptomatic and the comfort of the device was excellent, with no groin pain during the deployment, immediately after, at 7, and 30-days after the procedure.
