Heartlight Overview

Electrophysiologists treating atrial fibrillation know how important procedural control is to patient outcomes. That’s why HeartLight’s direct anatomic visualization, titratable laser energy, and universal balloon design make it a new standard for PVI procedures.

Cardio Graph

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
  • Eliminates total reliance on maps and other surrogate visualization methods
  • Full-color perspective enhances depth perception

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

Universal Balloon Design

Universal Balloon Design
Any vein. Any time.

The tapered, low-pressure compliant HeartLight balloon expands to fit a wide range of patient anatomies and optimizes vein contact.

  • Progressively inflatable until optimal vein occlusion is achieved
  • Enables a wide range of pulmonary veins to be isolated
  • Allows for treatment of anatomic variations such as common trunks, early branching and small middle veins

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.

RF Contact Sensing 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.

  • 4,500 patients treated
  • More than 80 peer-reviewed publications and abstracts
  • First balloon-based ablation technology to complete a successful FDA randomized pivotal trial in comparison to a gold standard RF technique
  • Demonstrated a statistically significant lower incidence of PV reconnection during the procedure in comparison to RF1

  • Exploratory analysis showed that physicians performing 15 or more HeartLight procedures achieved outcomes that compare to RF1

  • Utilizes 50 percent less energy to perform ablations in comparison to RF2,3

  • Published, single-center, non-randomized data suggests durability of treatment effect through four years4

HEARTLIGHT PUBLICATIONS

1. HeartLight Catheter, Endoscope, and Balloon Fill Media IFU.

2. 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.

3. 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.

4. Šedivá L, Petrů J, Škoda J, et al. Visually guided laser ablation: a single-centre long-term experience. Europace. 2014;16:1746–1751.

Heartlight Components

AN INSIDE LOOK AT HEARTLIGHT TECHNOLOGY.

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

  • Balloon Catheter

    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 ostium.

  • 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.