AtriCure Announces the First Patient Treated in the HEAL-IST Clinical Trial
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.”
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.
Chief Financial Officer
Vice President, Corporate Marketing & Communications
About Business Wire
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
MRM Health Starts Clinical Trial with Next-Generation Optimized Consortium Therapeutic MH002 in Pouchitis28.6.2022 11:23:00 CEST | Press release
MRM Health, a clinical-stage biopharmaceutical company developing next-generation live microbiome consortia therapeutics, announced today that they have received regulatory approval from the Federal Agency for Medicines and Health Products (FAMHP) in Belgium to start a Phase 2 trial with the novel next-generation optimized consortium therapy, MH002, in patients with Pouchitis. MH002 is the first, rationally designed, consortium therapy, in which key disease-driving mechanisms guide therapeutic microbial strain selection, to enter clinical development in Pouchitis. Pouchitis (inflammation of the surgically constructed pouch after colectomy) is the most prominent complication after surgical removal of the large bowel (colectomy) that is performed as a last resort treatment in Ulcerative Colitis (UC). Pouchitis occurs in up to 50% of these patients within 1-2 years after surgery. Disease mechanisms include impaired gut wall barrier function linked to gut microbiome dysbiosis, translocatio
L&T Technology Services Inaugurates Engineering Design Centre in France28.6.2022 10:00:00 CEST | Press release
L&T Technology Services Limited (BSE: 540115, NSE: LTTS), a leading global pure-play engineering services company, inaugurated its Engineering Design Centre (EDC) in Toulouse, France, to initially cater to the new age digital requirements of the global aerospace and defence sectors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220627005829/en/ Seen in the picture during the Ribbon Cutting Ceremony (from left to right): Deepanshu Khurana, Embassy of India; Véronique Canceill, Airbus; Amit Chadha, LTTS; Patrice Vassal, Invest in Toulouse; Marie-Eve Rigollet, Airbus (Photo: Business Wire) The EDC will initially focus on developing cutting-edge solutions for the aerospace and defence industries and LTTS will work with major OEMs in the region as an engineering partner. The center will specialize in end-to-end solutions for aerospace design & manufacturing, with a workforce of LTTS engineers having proven expertise in digital e
Turkish Medical Team Separates Conjoined Twins in 9 Hours, Breaking World Record28.6.2022 09:43:00 CEST | Press release
A Turkish medical team has successfully separated conjoined twins shortly after birth by employing a range of innovative techniques, including virtual simulations and 3D modeling. Carried out at Istanbul’s Acibadem Hospital, the successful procedure set a new world record for the fastest-ever operation of its kind. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220627005307/en/ Turkish Medical Team Separates Conjoined Twins in 9 Hours, Breaking World Record (Photo: Business Wire) “Thanks to our team of dedicated professionals, we were able to separate the twins in a well-planned surgical procedure that took about nine hours,” Prof. Mehmet Veli Karaaltin, who supervised the operation, says. He is an M.D. specialized in aesthetic, plastic and reconstructive surgery. As a result of the procedure, the twins, who were born conjoined at the breastbone but has two hearts, were both able to survive on their own. Born in Algeria, the
Denodo Recognized as an Enterprise Data Fabric Leader by Independent Analyst Firm Evaluation28.6.2022 09:00:00 CEST | Press release
Denodo, a leader in data management, today announced that Forrester Research, Inc., a leading independent technology and market research company, has positioned Denodo as a Leader in The Forrester Wave™: Enterprise Data Fabric, Q2 2022. According to the report, “Denodo is best fit for customers that are focusing on an enterprise-wide data fabric strategy to support BI, data collaboration, customer intelligence, data engineering, data science, IoT analytics, operational insights, and predictive analytics use cases.” The complete and complementary report, published on June 23, is available here. The Wave revealed that organizations want real-time, consistent, connected, and trusted data to support their critical business operations and insights. However, new data sources, slow data movement between platforms, rigid data transformation workflows, and governance rules, expanding data volume, and distributed data across clouds and on-premises, can cause organizations to fail when executing
Founders launch Plural: a €250m fund for fellow ‘Unemployables’ building Europe’s next generation of tech companies28.6.2022 09:00:00 CEST | Press release
Plural, a new investment platform started by the founders and backers of Europe’s most significant tech companies, has unveiled today a €250m early stage venture fund (Plural Platform SCSp RAIF, “Plural”) to back the next generation of founders with global ambitions. Set up by Ian Hogarth, Khaled Heloui, Sten Tamkivi and Taavet Hinrikus - with other recognised founders who will announce themselves soon - Plural is a scalable investment platform whose investors are exclusively former founders and operators with decades of company building experience. Plural was founded because the Plural founders saw that across Europe the vast majority of investors lacked experience of building tech businesses. In Europe just 8% of investors are former operators, in contrast to more than half of tech investors in the US. Plural’s founders believe that the scar tissue from building tech companies is invaluable in helping the next generation of founders to build companies with global potential. Plural’s
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom