FDA approves CyndRx's bioabsorbable AbsorbaSeal closure device after a 931-day PMA review

MedDevice Startups Staff · Jun 5 · 2 min read · Via CyndRx release

FDA approved CyndRx's AbsorbaSeal 5.6.7F Vascular Closure Device on June 5. The PMA, P230038, covers percutaneous closure of femoral arterial access sites after diagnostic or interventional catheterization through 5, 6 or 7F sheaths. Reduced time to hemostasis and ambulation is the labeled benefit. FDA received the application on November 17, 2023; the review ran 931 days. AbsorbaSeal is fully bioabsorbable and leaves no permanent or collagen-based implant behind. The company is pitching that to electrophysiology, interventional cardiology, vascular surgery and interventional radiology.

The SEAL TO HEAL IDE trial began in 2022 under national principal investigator Ross Milner of University of Chicago Medicine. It targeted 220 patients at U.S. private, academic and office-based labs. Two earlier European studies supported the CE mark. CyndRx, an LLC in Brentwood, Tennessee, has not disclosed investors, and its release carries no trial numbers. The Summary of Safety and Effectiveness Data on FDA's site is where the 220 patients' results will be read. For a first PMA at a company this size, that document is the asset.

Questions & Answers

What did FDA approve for CyndRx under P230038?

FDA approved CyndRx's AbsorbaSeal 5.6.7F Vascular Closure Device on June 5, 2026. It closes femoral arterial access sites after catheterization through 5, 6 or 7F sheaths, with reduced time to hemostasis and ambulation.

How long was the FDA review of CyndRx's AbsorbaSeal PMA?

FDA received the AbsorbaSeal PMA on November 17, 2023, and approved it on June 5, 2026, a review of 931 days.

What is the SEAL TO HEAL trial?

SEAL TO HEAL is CyndRx's U.S. IDE trial of the AbsorbaSeal 5.6.7F device, launched in 2022 with a 220-patient target. Ross Milner of University of Chicago Medicine is the national principal investigator.

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