Description

The Novatome™ Endomyocardial Biopsy Forceps, crafted by Scholten, is a specialized surgical instrument designed for precise cardiac tissue sampling. This device is essential for diagnosing various cardiac conditions such as myocarditis, cardiomyopathies, transplant rejection, and cardiac tumors. Its design facilitates percutaneous access through the internal jugular or subclavian veins, or the femoral artery, allowing for effective biopsy of the heart's ventricles.

Key Features

• Advanced Cutting Mechanism: The forceps feature a unique hollow ground cutting edge with a single-action jaw, ensuring superior sharpness and precise alignment. This design minimizes tissue compression while maximizing specimen size and quality.
• Flexible Navigation: Equipped with a polymer-coated flexible shaft and a formable distal curve, the device offers excellent torsion control and steerability. This allows for seamless navigation through the tricuspid valve and accurate positioning, aided by heart rhythm feedback.
• Ergonomic Handle Design: The actuating handle, available in a locking finger ring or two-ringed design, adapts to thumb positioning for enhanced control and comfort during use.

Safety and Convenience

• Single-Use Design: The disposable nature of the forceps eliminates contamination risks, enhancing patient safety. Each unit is pre-packaged sterile in a protective tray with an easy peel pouch for convenience.
• Regulatory Compliance: The device is CE marked and cleared under FDA 510(k) K072051, ensuring compliance with medical standards. It is intended for prescription use only, as per 21 CFR 801.109.

Specifications

• Available Sizes: French sizes 6, 7, 8, and 9 Fr with shaft lengths of 50 cm, 70 cm, and 100 cm. Jaw cup diameters range from 1.99 mm to 3.0 mm, with both curved and straight tip options.
• Material Composition: Constructed with stainless steel jaws and actuation wire, a fluoropolymer tubing sheath, and a high-performance polymer handle.

Manufacturing Excellence

Manufactured in the USA, the Novatome™ Forceps are assembled in clean room environments using advanced CNC machining and multi-step component inspection. This meticulous process ensures high precision and reliability, making it a trusted tool for cardiac specialists in healthcare facilities worldwide.

With Patent No. 7488296, this innovative device represents a commitment to quality and performance, providing healthcare professionals with the tools needed for effective and safe cardiac care.