Heartlight Overview

The HeartLight Excalibur balloon takes the establishment of rapid contact to new levels.

Electrophysiologists treating Atrial Fibrillation know how important durable lesion creation is to patient outcomes. That’s why HeartLight’s direct tissue visualization, titratable laser energy, and universal balloon design make it a new standard for pulmonary vein isolation (PVI) procedures.



Direct Visualization
See it. Believe it.

With a direct, “catheter-eye’s” view of the anatomy, HeartLight’s reusable 2Fr endoscope provides unmatched real-time assurance that ablations are on target.

  • Enables precise laser energy delivery
  • Full-color perspective enhances depth perception
  • Clear view of tissue contact



Maximize Control

Titratable Laser Energy
Maximize Control.

HeartLight delivers focused laser energy, enabling precise lesions optimized for variations in anatomy.

  • Titratable energy delivery enables isolation of veins using levels from 5.5W to 12W
  • Allows full rotational and axial energy positioning capabilities—without moving the balloon
  • Applies energy in a series of continuous 30° arcs, and can be freely directed to any area, creating precisely-tailored lesion sets


Technology Comparison

the HEARTLIGHT difference is CLEAR TO SEE

Compare our direct visualization, titratable energy, and universal balloon with other PVI modalities, and the conclusion is unmistakable—there is no comparison.

Radio Frequency CryoBalloon HeartLight
ABLATION THERAPY
LASER ENERGY SOURCE
CAPABILITY FOR DIRECT ANATOMICAL VISUALIZATION
CAPACITY FOR LOCALIZED ENERGY TITRATION
ELECTROANATOMICAL MAPPING INDEPENDENT*
DYNAMIC CAPACITY TO FIT ALL ANATOMIES

*Based on FDA approved studies

 


Clinical Data

ESTABLISHING A NEW STANDARD FOR PVI.

Data demonstrate a safe, efficient procedure that results in durable positive clinical outcomes.

  • PVs RECONNECTED DURING PROCEDURE

    PVs RECONNECTED DURING PROCEDURE

    In Pivotal trial, demonstrated a statistically significant lower incidence of PV reconnection during the procedure in comparison to RF.1

  • PRIMARY EFFICACY
    PIVOTAL TRIAL
    EFFICACY

    Pivotal trial
    Pivotal trial demonstrated 61.1% freedom from AF for HeartLight group, versus 61.7% for control at 90 days.1

    REAL-WORLD
    EFFICACY

    Real-world Efficacy
    A recent meta-analysis demonstrated a pooled estimate of 74.3% freedom from paroxysmal AF at 12 months.2

    Definition of success varies between studies.

  • SAFETY
    PIVOTAL TRIAL
    SAFETY


    The pivotal trial demonstrated that 5.0% of patients treated by experienced users (≥15 cases) with HeartLight experienced primary adverse events compared to 13.8% in the less experienced group (<15 cases).1

    EXPERIENCED
    USER SAFETY


    The pivotal trial demonstrated that 5.0% of patients treated by experienced users (≥15 cases) with HeartLight experienced primary adverse events compared to 13.8% in the less experienced group (<15 cases).1

  • META-ANALYSIS OF ACUTE SUCCESS
    PIVOTAL TRIAL
    ACUTE SUCCESS

    Pivotal trial success
    The HeartLight pivotal trial demonstrated an acute pulmonary vein isolation rate of 97.7%.1

    META-ANALYSIS
    OF ACUTE SUCCESS

    Meta-analysis success
    A meta-analysis examining 17 published manuscripts (N=1188) found that in patients treated with HeartLight, 98.8% of targeted pulmonary veins were successfully isolated at procedure end.2

  • META-ANALYSIS OF 12 MONTH SUCCESS

    META-ANALYSIS OF 12 MONTH SUCCESS

    A meta-analysis of patients treated with HeartLight for paroxysmal atrial fibrillation demonstrated a pooled estimate of 74.3% freedom from atrial arrhythmia for patients with paroxysmal AF at 12 months.2 The pivotal trial demonstrated 61.1% freedom from AF at 90 days.1 Definition of acute success varies between studies.

  • FREEDOM FROM AF AT 4 YEARS

    FREEDOM FROM AF AT 4 YEARS

    HeartLight long-term data shows stability in freedom from AF out to 4 years in a single-center study.3

  • ENERGY PER TREATMENT

    ENERGY PER TREATMENT

    Utilizes 50 percent less energy to perform ablations in comparison to RF4,5


Heartlight Components

AN INSIDE LOOK AT HEARTLIGHT TECHNOLOGY.

The HeartLight Endoscopic Ablation System consists of the Excalibur balloon catheter, endoscope, deflectable sheath, and integrated console. Together, they form a unique system offering direct visualization, titratable energy delivery, and universal balloon design.

  • Excalibur Balloon Catheter

    Excalibur Balloon Catheter

    An inflatable balloon is located at the distal end of the disposable, 12F, multi-lumen catheter. Separate lumens provide access for the lesion generator, illumination fibers, balloon inflation/deflation circuit, and endoscope. Made of a highly compliant material, the balloon’s shape is designed to adapt dynamically to the various anatomies encountered, while providing wide areas of contact surrounding the pulmonary vein antrum.

  • Endoscope

    Endoscope

    The reusable endoscope is a 500-micron diameter device with a wide, 110-degree field of view. It is inserted into the balloon catheter at the beginning of a procedure, and advanced until the camera at the tip reaches the proximal end of the balloon. From there, it provides confirmation of cardiac tissue contact, a unique feature of the HeartLight System. This enables the physician to directly observe where tissue is in contact, in order to precisely monitor and adjust the actual location for energy delivery. The endoscope is reusable for approximately 10 procedures.

  • Deflectable Sheath

    Deflectable Sheath

    The 12F ID deflectable sheath is inserted in the femoral vein and advanced into the left atrium via a transseptal puncture. The uni-directional and steerable sheath can be deflected up to 180 degrees, providing easy access to each of the four pulmonary veins, and facilitating placement of the balloon catheter.

  • HeartLight Console

    HeartLight Console

    All of the functions necessary to perform ablation procedures with the HeartLight Endoscopic Ablation System are contained within a single compact console. Adjustment of the universal balloon, management of the endoscopic image, and selection of energy delivery parameters are easily activated from the console’s touch screen.


Live Case Video

HeartLight Excalibur Balloon Live Case
AF Symposium
 
This case, broadcast live to the AF Symposium in Orlando, FL from Na Homolce Hospital in Prague, Czech Republic, highlights the benefits of the Excalibur balloon. Drs. Petr Neužil, Vivek Reddy, and Jan Petrů achieve first time isolation of all four pulmonary veins with the ultra-compliant Excalibur balloon creating a contiguous, circumferential antral lesion set.



  1. HeartLight Catheter, Endoscope, and Balloon Fill Media IFU.
  2. Reynolds MR, Zheng Q, Doros G. Laser balloon ablation for AF: A systematic review and meta‐analysis. J Cardiovasc Electrophysiol. 2018;29:1363-1370.
  3. Šedivá L, Petrů J, Škoda J, et al. Visually guided laser ablation: a single-centre long-term experience. Europace. 2014;16:1746–1751.
  4. Martinek M, Lemes C, Sigmund E, et al. Clinical impact of an open-irrigated radiofrequency catheter with direct force measurement on atrial fibrillation ablation. Pacing Clin Electrophysiol. 2012 Nov;35(11):1312–1318.
  5. Bordignon S, Chun KRJ, Gunawardene M, et al. Energy titration strategies with the endoscopic ablation system: lessons from the high-dose vs. low-dose laser ablation study. Europace. 2013;15:685-689. doi:10.1093/europace/eus352.