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The Heart Laser-Tm Co2 Tmr System (the Heart Laser)

FDA PMA

Class III (US FDA PMA)

PMA P950015

by Laser Engineering Heart, Inc.

Identity

Trade Name
THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION FDA PMA
Generic Name
SYSTEM, LASER, TRANSMYOCARDIAL REVASCULARIZATION FDA PMA

Identifiers

PMA Number
P950015 FDA PMA
FDA Product Code
MNO FDA PMA

Classification

Device Class
Class III FDA PMA
Advisory Committee
Cardiovascular FDA PMA
FDA Decision
APWD FDA PMA

The Heart Laser CO₂ TMR System is a Class III laser-based device classified under the generic name System, Laser, Transmyocardial Revascularization. It is designed for transmural revascularization, a procedure intended to create channels in the myocardium to improve blood flow in patients with stable angina refractory to conventional treatments.

This system is supplied as a medical device authorized under FDA PMA (Premarket Approval) with PMA number P950015. It is intended for use in clinical settings where coronary artery atherosclerosis is not amenable to direct revascularization, as specified in the advisory committee classification under Cardiovascular (CV). The device is not described as single-use or reusable, nor are MRI safety or sterility details provided in the specifications.

Frequently asked questions

What is the primary clinical use of the Heart Laser CO₂ TMR System, and who is it intended for?

The Heart Laser CO₂ TMR System is designed for transmural revascularization, creating channels in the heart muscle (myocardium) to improve blood flow in patients with stable angina (Canadian Cardiovascular Society class 3 or 4) that hasn’t responded to conventional treatments. It’s specifically approved for use in patients with coronary artery atherosclerosis that cannot be treated through direct revascularization methods like bypass surgery or angioplasty.

Is this device intended for single-use or repeated use in clinical settings?

The provided documentation does not explicitly state whether the Heart Laser CO₂ TMR System is single-use or reusable. Clinicians should refer to the manufacturer’s instructions for use (IFU) or service manuals for proper handling and reprocessing guidelines, as these details are not included in the regulatory filing.

How is the Heart Laser CO₂ TMR System regulated in the U.S., and what approval pathway was followed?

The Heart Laser CO₂ TMR System is classified as a Class III medical device under the FDA’s Premarket Approval (PMA) pathway, with approval granted under PMA number P950015. This indicates it underwent a rigorous review by the FDA’s advisory committee (Cardiovascular, CV) before receiving clearance for commercial distribution.

What types of patients are considered candidates for this procedure based on the approved indication?

The system is approved for patients with stable angina (CCS class 3 or 4) caused by coronary artery atherosclerosis that is not amenable to direct revascularization (e.g., bypass surgery or angioplasty). It is specifically intended for those who remain symptomatic despite optimal medical therapy, as outlined in the FDA’s approved indication.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Laser Engineering Heart, Inc.

Sources (1)

  • FDA PMA P950015 24 fields · synced Oct 6, 2026