đź“‹ FDA Reference
olympus angioscopy sheath
Olympus
Summary: The Olympus Angioscopy Sheath is a medical device used for visualizing blood vessels during procedures. It is primarily used by interventional radiologists and vascular surgeons.
FDA Clearance Information
Pathway
510K
Number
K873100 ↗
Decision Date
February 29, 1988
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Olympus Angioscopy Sheath was cleared through the FDA 510(k) pathway on February 29, 1988. It is manufactured by Olympus and classified as a Class 2 device.
What It Is
The Olympus Angioscopy Sheath is a flexible sheath designed to facilitate the insertion of an angioscope into blood vessels. It allows for direct visualization of the vessel lumen, aiding in the diagnosis and management of vascular conditions. The sheath is typically used in conjunction with other interventional tools like balloon catheters or lasers.
Clinical Applications
This device is commonly used in procedures such as transluminal balloon angioplasty and laser angioplasty, particularly in patients with chronic vascular occlusions. It is frequently utilized in settings where detailed visualization of the vascular interior is necessary, such as in the management of arteriovenous fistulae in hemodialysis patients. Vascular surgeons and interventional radiologists are the primary users.
Indications for Use
The FDA indications suggest that the device is intended for use in visualizing blood vessels to assist in procedures like angioplasty. It is particularly useful for patients with vascular occlusions or those undergoing dialysis.
Practical Considerations
The sheath is compatible with a 2.7 mm diameter angioscope and is typically used with a 9F sheath size. It is important to ensure compatibility with other interventional tools, such as balloon catheters or lasers, during procedures.
Related Literature
The linked study investigated the use of angioscopy in managing occlusions in hemodialysis fistulae. Using the Olympus angioscope and sheath, the study involved 27 patients and demonstrated that angioscopy could effectively guide balloon and laser angioplasty. The study found that most patients maintained vessel patency for up to 9 months, though some required additional interventions. Limitations include the small sample size and the focus on a specific patient population.
Frequently Asked Questions
What is the Olympus Angioscopy Sheath used for?
It is used for visualizing blood vessels during procedures like angioplasty, aiding in the diagnosis and management of vascular conditions.
What specialties typically use this device?
Interventional radiologists and vascular surgeons typically use the Olympus Angioscopy Sheath.
What are the FDA-cleared indications?
The device is indicated for visualizing blood vessels to assist in procedures such as angioplasty, especially in patients with vascular occlusions.
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.