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FDA approvedFDA approved. Stage 4 of 4 (Authorized)

FDA Approves CyndRx's AbsorbaSeal Bioabsorbable Femoral Artery Closure Device

The premarket approval rests on the 220-patient SEAL TO HEAL study, in which no major access-site complications were recorded at 30 days.

By News DeskJune 9, 20262 min read
An external compression band device over a puncture site at the wrist
An external compression closure device on the radial artery at the wrist after cardiac catheterization. Not the AbsorbaSeal device, which closes femoral artery punctures from inside and outside the vessel. Oyoyoy, CC BY-SA 4.0, via Wikimedia Commons · CC BY-SA 4.0
FDA approvedPMA, high-risk device · P230038FDA approved. Stage 4 of 4 (Authorized)

The FDA approved this high-risk device through premarket approval (PMA), after reviewing clinical evidence of safety and effectiveness.

Key points

  • The FDA approved CyndRx's AbsorbaSeal 5.6.7F Vascular Closure Device under PMA P230038 on June 5, 2026; the company announced it on June 9.
  • The device seals femoral artery punctures after catheter procedures using 5, 6 or 7F sheaths, with a seal made of two bioabsorbable copolymers.
  • In the single-arm SEAL TO HEAL study the major access-site complication rate was 0.0% (0 of 219), and mean time to hemostasis was 1.71 minutes, according to the FDA summary.

CyndRx, a Brentwood, Tennessee, device maker, has received US Food and Drug Administration premarket approval for its AbsorbaSeal vascular closure device, which seals femoral artery puncture sites after catheter-based procedures, Endovascular Today reported on June 9, citing the company's announcement.

The FDA's premarket approval database lists the AbsorbaSeal 5.6.7F Vascular Closure Device under PMA P230038, received on November 17, 2023, with a decision date of June 5, 2026. It is indicated for percutaneous closure of femoral arterial access sites "while reducing times to hemostasis and ambulation" in patients who have had diagnostic or interventional catheterization through 5, 6 or 7F procedural sheaths.

How the device works

According to the FDA's summary of safety and effectiveness data, the device delivers a fully bioabsorbable sealing mechanism to the puncture site. The seal assembly is made of two bioabsorbable copolymers and compresses the artery wall between components outside the vessel, a proximal seal and floating foot, and components inside it, a gasket and distal seal, joined by a stem. It is delivered through a commercially available Galt Medical introducer set and comes in a single size. The summary lists no known contraindications.

CyndRx said the device is designed to reduce procedural complexity and avoids permanent and collagen-based implants, according to Endovascular Today.

The SEAL TO HEAL study

The approval was based on SEAL TO HEAL, a prospective, single-arm study run under an investigational device exemption at nine US sites. It treated 29 roll-in subjects and 220 pivotal subjects between May 13, 2022, and June 5, 2023; of the pivotal group, 102 had diagnostic and 118 had interventional procedures. Success was judged against preset performance goals rather than a control group.

The primary safety endpoint, the 30-day rate of major access-site closure-related complications, was 0.0% (0 of 219 subjects), against a performance goal of 6.0%. Mean time to hemostasis, the primary effectiveness endpoint, was 1.71 minutes across the combined group, against a performance goal of 20.8 minutes, and all subjects reached hemostasis within 30 minutes. Mean time to ambulation was 1.82 hours after diagnostic procedures and 3.15 hours after interventional ones, meeting goals of 6 and 11 hours.

"As a clinical investigator in the SEAL TO HEAL trial, I saw AbsorbaSeal deliver on the priorities that matter most to interventionalists regarding vascular access closure: reliable hemostasis, early ambulation, and no permanent implant left behind," interventional cardiologist Vishal Gupta said in the company's release, as quoted by Endovascular Today.

CyndRx said it will advance US commercialization and work with specialists in electrophysiology, interventional cardiology, vascular surgery and interventional radiology. It did not give a launch date or pricing in the coverage.

Sources

  1. FDA Approves CyndRx's AbsorbaSeal Vascular Closure Device, Endovascular Today, June 9, 2026
  2. PMA P230038: AbsorbaSeal 5.6.7F Vascular Closure Device (database record), US Food and Drug Administration, June 5, 2026
  3. Summary of Safety and Effectiveness Data, PMA P230038, US Food and Drug Administration, June 5, 2026