Description

The Novatome™ Endomyocardial Biopsy Forceps is a specialized medical device engineered for precise cardiac tissue sampling. Designed for single-use, this disposable and sterile bioptome is intended to enhance safety and convenience during endomyocardial biopsy procedures. Its primary function is to obtain high-quality biopsy samples from the heart's ventricles, accessed percutaneously through venous or arterial routes such as the internal jugular or subclavian veins, or the femoral artery.

Key Features

• Specimen Quality: The device is crafted to maximize specimen size while minimizing tissue compression, ensuring superior sample quality for accurate pathological analysis.
• Cutting Edge Design: Equipped with a unique hollow ground cutting edge, the forceps offer exceptional sharpness and cutting force, complemented by a single action cutting jaw for precise tissue acquisition.
• Handle and Control: The locking finger ring actuation handle provides a secure grip and excellent torsion control, enhancing the precision of the procedure.

Navigation and Positioning

• Formable Distal Curve: This feature allows for easy positioning and navigation through the tricuspid valve.
• Steerable Design: Improves access and provides feedback on heart rhythm, balancing flexibility and stiffness for optimal navigation and positioning.

Construction and Materials

• Components: Comprises cutting jaws, a polymer-coated flexible shaft, and a high-performance polymer actuating handle.
• Shaft Sheath: Made from fluoropolymer tubing, ensuring biocompatibility.
• Manufacturing: Assembled in clean room environments with advanced CNC machining, near zero tolerance processing, and multi-step component inspection for quality assurance.

Packaging and Availability

• Packaging: Each device is individually packaged in a sterile tray with an easy peel pouch.
• Configurations: Available in French sizes 6 Fr to 9 Fr, with shaft lengths of 50 cm, 70 cm, and 100 cm. Jaw cup diameters range from 2.0 mm to 3.0 mm, with curved or straight tip options.

Regulatory Compliance

• Certifications: The Novatome™ forceps is CE marked and FDA 510(k) cleared, classified under Regulation Number 21 CFR 870.4075 as a Class II device.
• Patent: Protected under Patent No. 7488236.

Testing and Performance

Non-clinical performance tests include dimensional, tensile, simulated biopsy yield, and cutting jaw force assessments. While no clinical studies have been conducted specifically on this device, over 30 years of clinical experience have informed its design.

Typical Use Environments

Ideal for use in cardiac catheterization labs, hospitals, and specialized cardiac care centers, the Novatome™ Endomyocardial Biopsy Forceps requires no maintenance due to its single-use design, offering a reliable and efficient solution for cardiac tissue sampling.