Description

The Novatome™ Endomyocardial Biopsy Forceps, crafted by Scholten Surgical Instruments, is a specialized tool designed for precise cardiac tissue sampling. This single-use, disposable device is sterile, ensuring maximum safety and convenience during endomyocardial biopsy procedures. Its primary function is to obtain biopsy samples from the ventricles of the heart, accessed through percutaneous venous or arterial routes such as the internal jugular or subclavian veins.

Design and Functionality

Engineered with a balance of flexibility and stiffness, the Novatome™ provides exceptional torsion control and ease of positioning. This design facilitates seamless navigation through the tricuspid valve into the ventricle, enhancing the accuracy and reliability of the biopsy process. The forceps are designed to maximize specimen size while minimizing tissue compression, thereby preserving the quality of the samples obtained.

Key Features

• Locking Finger Ring Actuation Handle: The two-ringed, hemostat-type handle offers adaptable thumb positioning, providing a solid and comfortable grip.
• Cutting Mechanism: Features a single action cutting jaw with a unique hollow ground cutting edge, ensuring precise and controlled tissue sampling.
• Formable Distal Curve: Enhances navigation and positioning within the heart.
• Steerable Shaft: Allows for effective maneuvering through the heart's structures, with feedback on heart rhythm.

Material and Manufacturing

Constructed from biocompatible materials, the forceps include stainless steel jaws and actuation components, a high-performance polymer handle, and a fluoropolymer flexible shaft sheath. Each unit is assembled in clean room environments using advanced CNC machining techniques, ensuring near zero tolerance processing and rigorous multi-step component inspection.

Packaging and Availability

Each forceps is supplied in a sterile protective tray with an easy peel pouch, available in various configurations:

• French Sizes: 6 Fr, 7 Fr, 8 Fr, 9 Fr
• Shaft Lengths: 50 cm, 70 cm, 100 cm
• Jaw Cup Diameters: 2.0 mm, 2.3 mm, 2.7 mm, 3.0 mm
• Tip Options: Curved or straight

Regulatory Information

The Novatome™ is CE marked and holds a 510(k) Number K072051, classified under Regulation Number 21 CFR 870.4075 as a Class II medical device. It is intended for prescription use only, aligning with regulatory standards to ensure quality and performance.

Clinical Background

With over 30 years of clinical experience based on its reusable predecessor, the Novatome™ has undergone extensive non-clinical performance testing, including dimensional, tensile, simulated biopsy yield, and cutting jaw force assessments. This robust testing framework underscores its reliability and effectiveness in clinical settings.