CardioFocus Announces Pulsed Field Ablation Milestones

MARLBOROUGH, Mass., July 19, 2022 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatments for atrial fibrillation (Afib), today announced several milestones toward the development of a next generation pulse field ablation (PFA) technology for treatment of AFib, including the formation of a clinical advisory board, filing of key patents and completing initial pre-clinical studies.

The company has closely followed recent developments in the energy delivery method known as irreversible electroporation, also referred to as PFA or Pulse Field Ablation, which utilizes an electric field with a high voltage current between electrodes to ablate cardiac tissue. PFA offers the potential of reducing certain safety concerns such as esophageal heating while performing cardiac ablation for Afib. Despite the promise of improved safety, recent scientific papers^1,2 have shown the need for the electrode to be in contact with the tissue to create a high-quality PFA ablation, bringing into question both the higher 'doses' currently being used in some PFA systems as well as the ultimate long-term chronic results.

CardioFocus is leveraging the outstanding clinical performance of its flagship HeartLight X3 System to address the shortcomings of the currently available catheters being used to deliver PFA for pulmonary vein isolation (PVI). More specifically, two decades of clinical experience have proven the HeartLight System is the best-in-class catheter to ensure catheter/tissue contact in the incredibly variable human pulmonary vein anatomy due to its highly compliant balloon and direct visualization. Patents for HeartLight PFA technology were filed earlier this year, and CardioFocus anticipates first human use in early 2023.

"With the wide variability in patient anatomies, the best results will be achieved by providing a catheter with the ability to quickly obtain tissue contact with all the various pulmonary vein anatomies, and then allowing physicians to choose their optimal energy source. Regardless of the energy source, we believe HeartLight enables best-in-class patient results by providing an ablation platform that will facilitate the creation of precise lesions and thereby predictable, efficient cases," said CardioFocus CEO & President Burke T. Barrett. "We are thrilled by the patient outcomes and the excitement we have seen with our HeartLight X3 laser-based therapy, and look forward to utilizing the HeartLight's highly compliant and flexible balloon delivered under direct visualization to develop a better PFA solution for PVI."

To help accelerate its groundbreaking developments in PFA, CardioFocus has assembled a Clinical Advisory Board (CAB) consisting of Vivek Reddy, M.D., Prof. Peter Neuzil, M.D., Andrea Natale, M.D., David E. Haines, M.D., and J. Michael Mangrum, M.D. The CAB has collaborated with CardioFocus on the development of the system and after review of the most recent studies issued the following statement: "We have all worked closely with CardioFocus for more than a decade and have used the HeartLight System clinically. We believe the unique HeartLight features of a highly compliant balloon coupled with direct visualization to confirm in real-time good balloon/tissue contact may ultimately provide a platform for optimized delivery of PFA because intimate electrode/tissue contact can be directly visualized. We are excited by the results of the initial pre-clinical work delivering PFA with the prototype system, where distinct and precise lesions were easily delivered circumferentially around pulmonary veins using direct visualization. This approach to PFA holds great promise." ³ 

Millions of patients suffer from Afib globally, and CardioFocus' mission is to deliver better long-term outcomes for those undergoing a PVI procedure. HeartLight is uniquely positioned to overcome the challenges of precise energy delivery caused by anatomic variability and pulmonary vein complexity. HeartLight combines a highly compliant balloon and direct visualization via an intra-cardiac camera to enable electrophysiologists to have total confidence in directing ablative energy into heart tissue. This precision allows for less power delivered without compromising clinical results and has the potential to reduce safety concerns associated with high power delivery. HeartLight X3 recently showed high lesion durability and one year freedom from atrial fibrillation, with data presented at HRS 2022.⁴

The HeartLight X3 System is a revolutionary catheter ablation technology for controlled and consistent pulmonary vein isolation (PVI), the gold standard treatment for atrial fibrillation (Afib). Using direct tissue visualization, titratable laser energy and compliant balloon technology, the HeartLight X3 System is a truly differentiated PVI solution. HeartLight is a treatment option for some patients whose Afib is insufficiently controlled with medication.⁵ More than 33 million patients worldwide suffer from Afib,⁶ which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity. HeartLight X3 offers a unique RAPID mode, which leverages a precise motor control system that enables uninterrupted, high-speed, circumferential lesion creation under direct control of the physician. Clinical studies of the HeartLight X3 System demonstrated that AFib patients can be treated quickly resulting in consistently reduced procedure times with excellent procedure time predictability.^7,8

Headquartered in Marlborough, MA, CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (Afib), the most common heart arrhythmia. The HeartLight X3 catheter, endoscope, sheath, console and balloon fill media are all manufactured in the USA. For more information, visit http://www.CardioFocus.com.

¹ Nakagawa et al., B-PO03-131 Effects of Contact Force on Lesion Size During Pulsed Field Ablation, Heart Rhythm, Vol. 18, No. 8, August Supplement 2021.

² Meckes D, Emami M, Fong I, Lau DH, Sanders P, PULSED-FIELD ABLATION: COMPUTATIONAL MODELLING OF ELECTRIC FIELDS FOR LESION DEPTH ANALYSIS, Heart Rhythm O2. 2022.

³ All members of the Clinical Advisory Board are consultants of CardioFocus for the development of the HeartLight Pulse Field Ablation System.

⁴ M. Funasako; Data presented at HRS 2022 Rhythm Theater from single-center, real-world study.  In a pivotal study of HeartLight X3 using stringent success definitions, 1 year chronic success was 72% for X3 and 61% for RF ablation. https://www.cardiofocus.com/wp-content/uploads/2022/05/schmidt-pivotal-study-novel-motor-driven-endoscopic-ablation-system.pdf

⁵ In the United States, the HeartLight System is indicated to treat drug refractory, symptomatic, paroxysmal atrial fibrillation (AFib).

⁶ Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.

⁷ X3 total procedure time was statistically significantly shorter than the original HeartLight and irrigated radiofrequency ablation (RF) ablation based on a comparison to the original HeartLight pivotal study (historical control).

⁸ Predictability is determined by the standard deviation of the procedure time.

Sean Leous
ICR Westwicke
646-866-4012
[email protected]

SOURCE CardioFocus, Inc.