Business Wire

AtriCure Announces the First Patient Treated in the HEAL-IST Clinical Trial

Share

AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced that the first patient was treated in the HEAL-IST™ trial (NCT 05280093). The first patient was treated by Drs. Mark LaMeir and Carlo de Asmundis at University Hospital Brussels. The HEAL-IST trial will evaluate the safety and effectiveness of AtriCure’s Isolator® Synergy™ Clamp for the treatment of drug-refractory patients diagnosed with Inappropriate Sinus Tachycardia (IST). Sinus tachycardia normally occurs when the body sends out signals to make the heart beat faster, such as when some people experience stress or physical exertion during exercise. When it happens unexpectedly or for no easily identifiable reason, the condition is called Inappropriate Sinus Tachycardia.

The HEAL-IST trial is a prospective, multicenter, single-arm study of 142 patients at up to 40 centers in the United States and Europe. The therapy being studied involves a hybrid epicardial and endocardial procedure, during which a cardiac surgeon and an electrophysiologist work together to create lesions on the right side of the heart. The primary effectiveness endpoint is freedom from IST, defined as having a mean heart rate of less than 90 beats per minute, or at least a 15% reduction in mean heart rate compared to a pre-operative baseline. The primary safety endpoint is procedure or device related adverse events through 30 days after the surgery is completed.

“Symptomatic IST is a serious arrhythmia that dramatically decreases the quality of life in predominantly younger adults, and more specifically, young women,” said Dr. LaMeir, Professor and Head of Cardiac Surgery at University Hospital Brussels, and co-principal investigator in the HEAL-IST trial. “Further, since current antiarrhythmic drug treatment has limited long-term effect, and societal guidelines do not advise sinus node ablation or modulation, this landmark study of sinus node sparing hybrid ablation has the potential to establish a standard of care for these patients.”

“We believe that cardiac surgeons and electrophysiologists working together is a safe and highly effective way to treat complex arrhythmias,” said Michael Carrel, President and Chief Executive Officer of AtriCure. “The HEAL-IST trial is an example of AtriCure’s commitment to, and leadership in improving the lives of patients. The therapy has the potential to significantly expand our addressable markets.”

“IST is a common disease that is often under or mis-diagnosed,” said Dr. de Asmundis, Professor and Director of Heart Rhythm Management at University Hospital Brussels, and co-principal investigator in the trial. “There are currently no approved treatments for this disease. The HEAL-IST trial, which is based on years of research from our clinic, has a chance to prove how successful this procedure can be.”

About AtriCure

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure’s AtriClip® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE® probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Angie Wirick
Investor Relations
Chief Financial Officer
(513) 755-5334
awirick@atricure.com

Valerie Storch-Willhaus
Media Relations
Vice President, Corporate Marketing & Communications
(612) 605-3311
vstorch-willhaus@atricure.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Ipsen to Acquire Epizyme, Expanding Its Portfolio in Oncology27.6.2022 07:00:00 CEST | Press release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220626005092/en/ Disclaimer: Intended for international media and investor audiences only Ipsen (Euronext: IPN; ADR: IPSEY) and Epizyme (Nasdaq: EPZM) today announced that they have entered into a definitive merger agreement under which Ipsen will acquire Epizyme. The transaction was unanimously approved by both Ipsen and Epizyme Boards of Directors and is anticipated to close by the end of the third quarter of 2022, subject to the satisfaction of all closing conditions. Epizyme is a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets for cancer patients. The primary focus of the acquisition is on the lead medicine, Tazverik® (tazemetostat), a first-in-class, chemotherapy-free EZH2a inhibitor, which was granted Accelerated Approval by the U.S. Food and Drug Administratio

The Group Announces the Beginning of An Open-Ended Share Repurchase Programme Of Prosus And Naspers Shares27.6.2022 06:00:00 CEST | Press release

The board of directors of Naspers Limited ("Naspers Board") (JSE: NPN; LSE: NPSN) and board of directors ("Prosus Board") of Prosus N.V. ("Prosus") (Euronext Amsterdam: PRX; JSE: PRX) are pleased to announce the beginning of an open-ended, repurchase programme in respect of the ordinary shares N in the capital of Prosus ("Prosus Shares") and N ordinary shares ("Naspers Shares") in the share capital of Naspers, from the respective Prosus and Naspers (together the "Group") free-float shareholders (together the "Repurchase Programme"). The Repurchase Programme is expected to efficiently unlock immediate value for the shareholders of Prosus ("Prosus Shareholders") and Naspers ("Naspers Shareholders"). Prosus will begin selling small numbers of ordinary shares in Tencent Holdings Limited (“Tencent”) held by the Group (“Tencent Shares”) regularly and in an orderly manner, while concurrently purchasing Prosus Shares and Naspers Shares pursuant to the Repurchase Programme, as long as the Group

The Group Announces the Beginning of an Open-Ended Share Repurchase Programme of Prosus and Naspers Shares27.6.2022 06:00:00 CEST | Press release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, INTO OR IN ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. PLEASE SEE THE IMPORTANT NOTICE AND DISCLAIMERS AT THE END OF THIS ANNOUNCEMENT. The board of directors of Naspers Limited ("Naspers Board") (JSE: NPN; LSE: NPSN) and board of directors ("Prosus Board") of Prosus N.V. ("Prosus") (Euronext Amsterdam: PRX; JSE: PRX) are pleased to announce the beginning of an open-ended, repurchase programme in respect of the ordinary shares N in the capital of Prosus ("Prosus Shares") and N ordinary shares ("Naspers Shares") in the share capital of Naspers, from the respective Prosus and Naspers (together the "Group") free-float shareholders (together the "Repurchase Programme"). The Repurchase Programme is expected to efficiently unlock immediate value for the shareholders of Prosus ("Prosus Shareholders") and Naspers ("Naspers Shareholders"). Prosus will begin sellin

EPPA : New Study Shows That Making Reusable Containers for Takeaway Obligatory Will Undermine the EU’s Environmental Goals27.6.2022 06:00:00 CEST | Press release

Obligatory reusable packaging in takeaway services would be more burdensome for the environment than continuing to use single-use paper-based packaging. This is the conclusion of a new meta-study assessment, commissioned by the European Paper Packaging Alliance and carried out by renowned engineering consultancy, Ramboll. As the European Commission prepares to propose a revision of the Packaging and Packaging Waste Directive (PPWD) with potentially far-reaching implications, the analysis, which examined 26 scientific studies, shows that reuse systems impose exclusive additional burdens to the environment when compared to single-use, related to additional washing, take-back transportation and breakage / unit loss associated with takeaway. The results show that Climate Change is by far the most affected impact category when implementing reuse in take-away services, and that reusable tableware can also have a significant impact on water use. Commenting on the meta-study assessment, Eric L

Teva Announces Promising Interim Results From Its Study PEARL, About the Impact of AJOVY ® (fremanezumab)24.6.2022 18:54:00 CEST | Press release

Teva Pharmaceuticals Europe B.V. today announces promising interim results from its Pan-European Real World study (PEARL), presented for the first time at the European Academy of Neurology (EAN) Congress in Vienna, Austria. The two-year Pan-European Real World (PEARL) prospective, observational study of AJOVY® (fremanezumab), looks at its effectiveness in patients with chronic migraine or episodic migraine, and is an ongoing study sponsored by Teva Pharmaceuticals Europe BV.1 These findings further offer insight into the treatment of migraine in real-world clinical practice. The interim findings were presented by Faisal Mohammad Amin, Associate Professor of Neurology at the University of Copenhagen, Denmark. Out of the total planned 1100 patients in PEARL, 389 patients are included in the interim analysis presented. These findings show that 54.7% of patients in the study had their monthly-migraine-days reduced by 50% or more, over the six-month period from the start of treatment. Addit