Tele: 561.316.3330
Breaking Medical Device News

Monday, October 18, 2021
HomeFDACardioFocus Announces Initial Commercial Procedures Following FDA Approval of HeartLight® X3 Ablation...

CardioFocus Announces Initial Commercial Procedures Following FDA Approval of HeartLight® X3 Ablation System for Treatment of Atrial Fibrillation

June 16, 2020

CardioFocus, Inc. announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight® X3 Endoscopic Ablation System.

CardioFocus said the revolutionary cardiac ablation technology is designed to treat drug-refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm disorder.

Henry D. Huang, M.D., FACC, FHRS of Rush University Medical Center in Chicago, and David Kenigsberg M.D., FACC, FHRS of Westside Regional Medical Center in Plantation, Florida performed the first procedures using the X3 System.

“We are dedicated to providing our patients the most efficacious and innovative treatment options for AFib, a common but treatable heart condition,” Dr. Huang said. “As the initial medical center in the U.S. to offer the HeartLight X3 System, we look forward to being able to provide effective symptom relief for Chicago-area patients safely, confidently and quicker than ever before. We are excited by the results we’ve seen thus far, which build upon the positive outcomes we experienced in treating more than 100 patients with previous versions of HeartLight.”

More than 2.3 million people in the U.S. suffer from AFib, and the numbers are climbing along with the aging population1. By 2050, AFib is expected to affect 15.9 million people2.

“Early on, I recognized the potential of the HeartLight System and after using it to treat more than 40 patients, I have been eager to offer the next-generation, HeartLight X3, to our patients here in South Florida,” said Dr. Kenigsberg. “I believe the technology has true game-changing potential in how it facilitates pulmonary vein isolation (PVI).”

The HeartLight® X3 Endoscopic Ablation System received U.S. Food and Drug Administration (FDA) approval for the treatment of drug-refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF) in May. Approval was based on a comprehensive submission, including outcomes from the study of 60 HeartLight X3 patients over 12 months. All study endpoints were achieved, and the device achieved very rapid PVI, in as few as three minutes for a single pulmonary vein.

“Following the impressive clinical trial results of HeartLight X3, we have been equally encouraged by these initial real-world patient experiences,” said Burke T. Barrett, Chief Executive Officer at CardioFocus. “Following the swift FDA approval, we are pleased to have begun a focused commercial rollout of the HeartLight X3 system in the U.S. that will showcase its impressive array of features.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Adam S. Epstein New CEO of AliMed, Inc.

In his prior role as Chief Commercial Officer, Epstein directed all customer-facing, demand generation and product development activities. Under his new leadership, AliMed will continue to build a robust portfolio of contracted positions with major, national GPO’s, IDN’s, and Distribution partners to drive sales growth.

Tony Collins Appointed CFO of Xenter

“Xenter is building a platform for medical innovations that is transformational. The only way we can achieve our objectives is if we have great leaders like Tony Collins leading our company,” stated Richard J. Linder, Founder, Chairman & CEO of Xenter, Inc. “Tony brings incredible depth and experience to his new role as Chief Financial Officer.

HistoSonics Receives FDA “Breakthrough Device Designation” for Novel Sonic Beam Therapy

Histotripsy of the liver provides clinicians the first automated external beam therapy using acoustic energy to mechanically destroy and liquefy tissue in the liver without incisions, ionizing radiation or heat.

Scott Sexton Appointed President at FIGUR8

"Scott brings to FIGUR8 30 years of workers' compensation, casualty, disability, and commercial health experience, most recently serving as a market leader for CorVel's national carrier practice sales team," said Nan-Wei Gong, CEO, and co-founder of FIGUR8.

Endolumik Inc. of Morgantown Secures $175,000 Angel Investment from Country Roads Angel Network

Endolumik, Inc. was founded in May 2020 by Mara McFadden, chief executive officer, and Dr. Nova Szoka, inventor of the surgical device.

Insulet Announces Board of Director Changes with Appointment of Luciana Borio, M.D. and Retirement of Sally W. Crawford

Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products, today announced...

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

By using this website you agree to accept Medical Device News Magazine Privacy Policy