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NOVATOME - Size: 7FG Length: 100

Product information

  • Quantity Unit Box
  • Product Code None

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Description

The Novatome™ Endomyocardial Biopsy Forceps is a specialized surgical instrument designed for precise cardiac tissue sampling. Intended for single-use, this disposable device enhances patient safety by eliminating contamination risks. It is expertly crafted for use in endomyocardial biopsy procedures, allowing healthcare professionals to obtain tissue samples from the heart's ventricles through percutaneous access.

Key Features

  • Single-Use Design: Ensures maximum hygiene and reduces cross-contamination.
  • Locking Finger Ring Handle: Provides familiar operation with a hemostat-type feel for secure handling.
  • Cutting Jaw Mechanism: Features a single action jaw with a unique hollow ground cutting edge for superior sharpness and control.
  • Formable Distal Curve: Offers ease of navigation and positioning within the heart.
  • Balance of Flexibility and Stiffness: Enhances torsion control and precise positioning.

Construction and Materials

  • Components: Includes cutting jaws, a polymer-coated flexible shaft, and an actuating handle.
  • Materials:
  • Stainless steel for jaws and mechanical parts
  • High-performance polymer for the handle
  • Fluoropolymer tubing for the flexible shaft sheath

Available Models

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

Manufacturing and Quality

  • Assembled in Clean Room Environments: Utilizes advanced CNC machining with near zero tolerance processing.
  • Multi-Step Component Inspection: Ensures high-quality performance and reliability.

Regulatory Information

  • CE Marked: Complies with international standards.
  • Manufactured in the USA: Adheres to Regulation Number 21 CFR 870.4075.
  • Regulatory Class: Class II, Product Code: DWZ

Performance Testing

Non-clinical performance tests include dimensional assessments, tensile strength evaluations, simulated biopsy yield, and cutting jaw force measurements. With over 30 years of clinical use history, the Novatome™ forceps is designed to set the standard for device performance in endomyocardial biopsy procedures.

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