Description

The Novatome™ Endomyocardial Biopsy Forceps, crafted by Scholten Surgical Instruments, is a specialized single-use, sterile device designed for precise cardiac tissue sampling. This disposable bioptome is expertly engineered for healthcare professionals to obtain biopsy samples from the right or left ventricle of the human heart, utilizing percutaneous venous or arterial access.

Design and Structure

• Cutting Jaws: Features a single-action cutting jaw with a hollow ground cutting edge, ensuring sharp and accurate specimen acquisition.
• Flexible Shaft: The polymer-coated shaft provides a balance of flexibility and stiffness, enhancing navigation and torsion control.
• Actuating Handle: Equipped with a high-performance polymer handle, including a hemostat-type finger ring, designed for ease of use and adaptability to any thumb position.

Unique Features

• Formable Distal Curve: Improves navigation and positioning within the heart.
• Locking Finger Ring: Offers a solid instrument feel, enhancing user control.
• Sample Quality: Engineered to maximize sample size while minimizing tissue compression, preserving the quality of the biopsy.

Safety and Performance

• Disposable Design: Eliminates contamination risks, ensuring maximum patient safety.
• Manufacturing Excellence: Assembled in clean room environments with advanced CNC machining, ensuring near zero tolerance processing and rigorous component inspection.
• Clinical Heritage: Builds on over 30 years of clinical experience from its reusable predecessor.

Specifications

• French Sizes: Available in 6 Fr, 7 Fr, 8 Fr, and 9 Fr.
• Shaft Lengths: Common lengths include 50 cm and 100 cm.
• Jaw Cup Diameters: Ranges from 2.0 mm to 3.0 mm.
• Materials: Constructed with stainless steel components and fluoropolymer tubing, ensuring biocompatibility.

Packaging

Each forceps is packaged in a sterile, protective tray with an easy peel pouch, ready for immediate use.

Regulatory Compliance

• CE Marked: Complies with the Medical Devices Directive 93/42/EEC.
• FDA 510(k) Cleared: Registered under number K072051.
• Global Registrations: Includes registrations with the FDA, Australian TGA, Health Canada, and others.
• Quality Certification: Adheres to EN ISO 13485:2016 standards and the Medical Device Single Audit Program (MDSAP).

Patent Information

Protected under US Patent No. 7488296, the Novatome™ forceps is a testament to innovative design and reliable performance, making it an essential tool for cardiac biopsy procedures.