Description

The Novatome Biopsy Forceps by Scholten is a specialized medical device meticulously designed for healthcare professionals engaged in cardiac tissue sampling. This single-use, disposable instrument is crafted to ensure sterility, significantly reducing the risk of contamination during endomyocardial biopsies. Its primary function is to obtain biopsy samples from the ventricles of the human heart through percutaneous venous or arterial access, such as the internal jugular or subclavian veins, or the femoral artery.

Key Features

• Advanced Cutting Technology: Equipped with a unique hollow ground cutting edge, the forceps offer superior sharpness and enhanced cutting force. The single action cutting jaw and precise cutting edge alignment, achieved through super precision machining, ensure clean and effective tissue sampling.

• Ergonomic Design: The device features a familiar locking finger ring actuation handle, ergonomically designed to adapt to any thumb position, providing comfort and control during use.

• Navigational Ease: Its formable distal curve allows for easy positioning and navigation within the heart, balancing flexibility and stiffness for excellent torsion control. This design enhances steerability and provides feedback in response to heart rhythms, crucial for precise operation.

Material and Construction

Manufactured from biocompatible materials, the Novatome Biopsy Forceps includes stainless steel jaws and actuation wire, a high-performance polymer handle, and a polymer-coated flexible shaft with fluoropolymer tubing. Each unit is assembled in a clean room environment, ensuring high quality through multi-step component inspection and advanced CNC machining.

Packaging and Compliance

Each forceps is packaged sterile in a protective tray with an easy peel pouch, and is CE marked, aligning with regulatory standards. Available in various French sizes (6, 7, 8, 9 Fr) and shaft lengths (50 cm, 70 cm, 100 cm), with jaw cup diameters ranging from 2.0 mm to 3.0 mm, the device offers options for curved or straight tips to meet diverse clinical needs.

Performance and Reliability

With over 30 years of clinical experience backing its design, the Novatome Biopsy Forceps undergoes rigorous performance testing, including dimensional, tensile, simulated biopsy yield, and cutting jaw force assessments. Although no clinical studies have been conducted, it is deemed substantially equivalent to predicate devices, ensuring reliable performance.

Regulatory Information

Designed and manufactured in the USA, this Class II device (21 CFR 870.4075, Product Code: DWZ) is protected by Patent No. 7488296. Intended strictly for single use, it stands as a testament to Scholten's commitment to quality and innovation in medical device engineering.