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destino twist steerable guiding sheath
Oscor
Summary: The destino twist steerable guiding sheath is a medical device used for precise catheter navigation in endovascular procedures. It is primarily used by interventional radiologists and cardiologists to facilitate access to challenging vascular anatomy.
FDA Clearance Information
Pathway
510K
Number
K140406 ↗
Decision Date
April 17, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The destino twist steerable guiding sheath was cleared through the FDA 510k pathway on April 17, 2014. Manufactured by Oscor, it is classified as a Class 2 device under product code DYB.
What It Is
The destino twist steerable guiding sheath is a flexible, steerable sheath designed to aid in the navigation of catheters through the vascular system. It features a steerable tip that allows for precise control and maneuverability, making it particularly useful in complex vascular procedures. This device is designed to enhance the clinician's ability to access difficult-to-reach areas within the vasculature, improving procedural outcomes.
Clinical Applications
The destino twist steerable guiding sheath is commonly used in interventional radiology and cardiology for procedures such as embolization, angioplasty, and stent placement. It is particularly beneficial in cases where vascular anatomy is tortuous or challenging to navigate. The device is suitable for use in both hospital and outpatient settings, and is often employed in patients requiring precise catheter placement for diagnostic or therapeutic interventions.
Indications for Use
The FDA indications for the destino twist steerable guiding sheath suggest its use in procedures requiring precise catheter navigation and placement. It is intended for patients undergoing vascular interventions where traditional sheaths may not provide adequate control or access.
Practical Considerations
The destino twist steerable guiding sheath is available in various sizes to accommodate different patient anatomies and procedural requirements. It is compatible with a range of catheters and guidewires, making it versatile for use in multiple procedures. Clinicians should be familiar with the device's steering mechanism to optimize its use during interventions.
Related Literature
The linked study explored the use of steerable and precurved guiding sheaths in endobronchial procedures, specifically for lung biopsy under augmented fluoroscopy and cone beam CT guidance. The study highlighted the potential of these devices to improve targeting accuracy in endobronchial navigation. However, limitations included the need for further research to validate these findings across larger patient populations and diverse clinical settings.
Frequently Asked Questions
What is destino twist steerable guiding sheath used for?
It is used for precise navigation and placement of catheters in complex vascular procedures.
What specialties typically use this device?
Interventional radiologists and cardiologists commonly use this device.
What are the FDA-cleared indications?
It is indicated for procedures requiring precise catheter navigation and placement in vascular interventions.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.