Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device

Area of Science:

• Cardiovascular Research
• Medical Device Innovation
• Interventional Cardiology

Background:

• Left atrial appendage (LAA) occlusion is an alternative to anticoagulation for stroke prevention in atrial fibrillation.
• Current LAA occlusion devices have limitations hindering widespread adoption.
• Preclinical evaluation of the novel Conformal Left Atrial Appendage Seal (CLAAS) device is presented.

Purpose of the Study:

• To assess the conformability and sealing capabilities of the CLAAS device in preclinical settings.
• To compare the CLAAS device's performance against an existing LAA occlusion device.

Main Methods:

• In vitro conformability testing of CLAAS (27mm, 35mm) and Watchman 2.5 (27mm) devices using compressed silicone tubes.
• Acute and chronic 60-day canine studies involving device implantation.
• Gross and histological assessment of device performance and tissue response.

Main Results:

• CLAAS devices conformed to various oval orifice sizes, demonstrating superior adaptability compared to the Watchman 2.5.
• Successful implantation in canine models showed complete seal without thrombus formation.
• Histology at 60 days revealed complete neointimal coverage with minimal inflammation.

Conclusions:

• Preclinical data confirm the CLAAS implant's conformability and effective LAA sealing.
• The CLAAS device shows potential for improved LAA occlusion therapy.
• Ongoing clinical studies will further define its utility in atrial fibrillation patients.