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, and sterile instrument is tailored for endomyocardial biopsy procedures, ensuring high-quality specimen acquisition from the right or left ventricle via percutaneous access.

Key Features

• Safety and Convenience: As a single-use device, it offers enhanced patient safety and eliminates the need for sterilization.
• Design: The manually operated, hand-held design includes a locking finger ring actuation handle, adaptable to any thumb position, providing a familiar and solid instrument feel.
• Cutting Mechanism: Features a single-action cutting jaw with a unique hollow ground cutting edge, ensuring superior sharpness and cutting force.

Advanced Navigation

• Formable Distal Curve: Allows for precise navigation and positioning within the heart.
• Balance of Flexibility and Stiffness: Offers ease of positioning and superior torsion control, complemented by heart rhythm feedback during use.

Precision Engineering

• Machining Excellence: Super precision machining aligns the cutting edges perfectly. Assembly occurs in clean room environments using advanced CNC machining with near zero tolerance processing.
• Inspection: Multi-step component inspection guarantees quality.

Packaging

• Protective Packaging: Each forceps is packaged singly in a protective tray with an easy peel pouch, maintaining sterility until use.

Construction Materials

• Components: Composed of stainless steel jaws, actuation wire, and mechanical parts. The handle is made from high-performance polymer, and the flexible shaft sheath is crafted from fluoropolymer tubing.
• Biocompatibility: All materials are biocompatible, ensuring safe interaction with cardiac tissues.

Size Variations

• French Sizes: Available in 6 Fr, 7 Fr, 8 Fr, and 9 Fr.
• Shaft Lengths: Options include 50 cm, 70 cm, and 100 cm.
• Jaw Cup Diameters: Ranges from 2.0 mm to 3.0 mm, depending on size.
• Tip Options: Available in curved or straight configurations.

Regulatory Compliance

• Certifications: CE marked and FDA 510(k) cleared, aligning with international standards.
• Quality Management: Adheres to EN ISO 13485:2016 and MDSAP compliance.

Global Registration

Registered with health authorities in the USA, Canada, Australia, Italy, and the Netherlands, ensuring widespread recognition and trust.

Performance Testing

Non-clinical performance tests include dimensional accuracy, tensile strength, simulated biopsy yield, and cutting jaw force. With over 30 years of clinical use history based on its reusable predecessor, the Novatome™ offers reliability and effectiveness.

Manufacturing

Manufactured in the USA, it holds Patent No. 7488296, with potential for additional sizes in the future, continuing a legacy of innovation in cardiac biopsy instrumentation.