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ivt coronary atherectomy system tec r
Intensive Technology
Summary: The IVT Coronary Atherectomy System TEC R is a medical device used for removing atherosclerotic plaque from coronary arteries. It is primarily used by interventional cardiologists in catheterization labs.
FDA Clearance Information
Pathway
PMA
Number
P910019 ↗
Decision Date
December 30, 1998
Product Code
MCX
Device Class
Class 3
Evidence
0 studies
The device was cleared through the FDA premarket approval (PMA) pathway on December 30, 1998. It is manufactured by Intensive Technology and classified as a Class III device.
What It Is
The IVT Coronary Atherectomy System TEC R is an atherectomy device designed to remove plaque from coronary arteries. It utilizes a rotating cutting mechanism to excise and remove atherosclerotic material, thereby improving blood flow. The device's recent update involves a transition from analog to digital motor control circuitry, enhancing precision and reliability during procedures.
Clinical Applications
This device is commonly used in interventional cardiology, particularly during percutaneous coronary interventions (PCI) to treat patients with coronary artery disease. It is employed in settings such as catheterization labs, where it aids in the management of complex lesions that are not amenable to balloon angioplasty alone. Patients who benefit from this device typically have significant coronary artery blockages that require mechanical plaque removal.
Indications for Use
The FDA indications for this device involve an upgrade to its motor control system, which enhances its performance during coronary atherectomy procedures. It is intended for patients with coronary artery disease requiring plaque removal to restore adequate blood flow.
Practical Considerations
The device is compatible with standard catheterization lab equipment and requires specific training for optimal use. Clinicians should be aware of the device's sizing options to match patient anatomy and lesion characteristics. Proper technique is crucial to minimize complications such as vessel perforation.
Frequently Asked Questions
What is the IVT Coronary Atherectomy System TEC R used for?
It is used for removing atherosclerotic plaque from coronary arteries to improve blood flow in patients with coronary artery disease.
What specialties typically use this device?
Interventional cardiologists typically use this device in catheterization labs during percutaneous coronary interventions.
What are the FDA-cleared indications?
The device is indicated for use in coronary atherectomy procedures, specifically with an updated digital motor control system for enhanced performance.
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.