LASTAC System
by G V Medical, Inc. PMA
Active
PMA P870071
Overview
The LASTAC System is a Device, Angioplasty, Laser, Coronary, classified as a Class III medical device. It combines an argon laser source with fiber optics and a specially designed balloon catheter to facilitate percutaneous transluminal coronary angioplasty by ablating atherosclerotic plaque, thereby restoring blood flow in narrowed coronary arteries.
This system is used in interventional cardiology procedures under fluoroscopic guidance. Supplied as a complete kit, it includes sterile components for single-use applications and requires specialized training for operation. Authorized under FDA_PMA (PMA Number P870071), it adheres to regulatory standards for laser-based coronary interventions, with subsequent design modifications tracked via supplements (e.g., S001).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP870071 | Date2 Feb 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA PMA Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- Generic Name
- DEVICE, ANGIOPLASTY, LASER, CORONARY
- PMA Number
- FDA Product Code
- LPC
- Device Class
- Class III
- Advisory Committee
- Cardiovascular
- FDA Decision
- APPR Approved
- PMA Supplement
- S001 (Normal 180 Day Track)
Other devices from G V Medical, Inc.
Questions
What specific type of coronary procedure is the LASTAC System designed to assist with, and how does it differ from traditional balloon angioplasty?
The LASTAC System is designed to facilitate **percutaneous transluminal coronary angioplasty (PTCA)** by using an argon laser to ablate atherosclerotic plaque, rather than just mechanically widening the artery like a traditional balloon catheter. This laser-based approach helps restore blood flow in severely narrowed coronary arteries by vaporizing plaque buildup, which can be particularly useful in cases where mechanical dilation alone may not be sufficient.
Is the LASTAC System intended for single-use or repeated use, and what does the sterile kit include?
The LASTAC System is **strictly for single-use only**, as it is supplied as a complete sterile kit. The kit includes all necessary components for one procedure, including the laser source, fiber optics, and the specially designed balloon catheter, ensuring sterility and safety for a single patient application.
What training or expertise is required to operate the LASTAC System, and why is this important?
Specialized training is required to operate the LASTAC System due to its advanced laser technology and interventional cardiology applications. This ensures proper handling, precise plaque ablation, and safe fluoroscopic guidance—critical factors in avoiding complications like arterial perforation or incomplete lesion treatment during coronary interventions.
How is the LASTAC System regulated by the FDA, and what does the PMA number indicate?
The LASTAC System is regulated under an **FDA Premarket Approval (PMA)** with PMA number **P870071**, reflecting its classification as a **Class III** device. This approval pathway is used for high-risk devices like laser-based coronary interventions, ensuring rigorous evaluation of safety and effectiveness before market authorization. Subsequent design changes (e.g., Supplement S001) are also tracked under this approval.