Galaxy Medical Releases ECLIPSE-AF Remapping Data at Stanford Biodesign Retreat and Update on System Interoperability
SAN CARLOS, California, July 28, 2021 — Galaxy Medical announced today that the ECLIPSE-AF
90-day remapping data, presented at the Stanford BioDesign New Arrhythmia Technologies retreat, demonstrated durable lesions and chronic pulmonary vein isolation (PVI). Also, the company has recently treated patients in the same study using CE-Marked catheters and mapping systems from Boston Scientific, Biosense Webster and Abbott.
The ECLIPSE-AF Trial launched in September 2020 to study the acute safety of Galaxy’s flagship CENTAURI™ system, which uses Pulsed Electric Field (PEF) technology to treat cardiac arrhythmias. Results for the first fifty patients who reached the 90-day remapping procedure were presented by Dr. Ante Anic, Electrophysiology Laboratory Director at University Clinical Hospital in Split, Croatia, and primary investigator of the study. Acute PVI was achieved in all 50 patients, with first pass isolation in 90% of pulmonary veins (PVs). In the 49 patients that were remapped, the per-PV isolation rate improved from 47% to 84% as PEF dose increased from the first to the third cohorts. Subsequent enrollments have been performed with an optimized treatment intensity and workflow. Gaseous emboli have not been observed on any activation and neurocognitive scores have remained unchanged from baseline. Twelve patients underwent pre-and post-procedure cranial MRI, and no cerebral lesions were detected with DWI and FLAIR.
“These initial results are very promising as compared to the current standard of care and as we continue to add more patients with optimized parameters, I am confident that the chronic isolation rates will remain high. Focal ablation is a cornerstone of my practice and with the efficacy data presented, I look forward to shifting my practice from radiofrequency to PEF, especially considering CENTAURI’s ability to integrate with market leading mapping systems” said Dr. Ani˜.
Dr. Shephal Doshi, Director of Electrophysiology at St. Johns Health Center and the Pacific Heart Institute Santa Monica, CA commented: “This data is exciting, especially since they are achieved with the focal catheters that we have much experience and comfort with. With the promise of PEF technology, we look forward to demonstrating the utility of focal PEF for various arrhythmias.” Dr. Doshi will be the National PI for Galaxy Medical’s upcoming US IDE Trial.
“From the moment we conceived the CENTAURI System, our mission has been to democratize PEF technology, leaving the choice of the mapping system and catheter to the electrophysiologist. Having successfully completed procedures in ECLIPSE-AF with Boston Scientific’s RHYTHMIA HDX, Biosense Webster’s CARTO 3 and Abbott’s Ensite systems, all with contact-force sensing catheters, we are now closer to realizing that promise. Furthermore, the 90-day remapping procedures have provided invaluable data to optimize the parameters of this complex form of energy and should be mandatory to compare efficacy outcomes across trials that vary in ablation technology and patient profiles. There is no doubt now that focal PEF ablation with CENTAURI yields durable lesions without gaseous emboli,” said Jonathan Waldstreicher, M.D., CEO of Galaxy Medical.
CENTAURI is an investigational device and not commercially available.
-
Most popular related searches
Related products
Related news
-
Resources to Mitigate Pseudomonas aeruginosa Infection Risks in Hospitals and Buildings throughout Puerto Rico
Pseudomonas is a type of bacteria that is found commonly in the environment, often in places like soil and water. Of the many different types of Pseudomonas, the one that most often causes infections in humans is known as Pseudomonas aeruginosa according to the Centers for Disease Control and Prevention (CDC). It can cause infections in the blood, lungs and potentially other parts of the body. While Pseudomonas aeruginosa lives in the natural environment, it can also sometimes be found in the built environment...
-
Anuncia Medical Announces the First Successful US Implant of the Company’s Newly Commercially Released ReFlow Mini Flusher Device for Hydrocephalus Patients
Intermountain Primary Children’s Hospital First in the Country to Implant this Next Generation FDA-Cleared Device Company Welcomes Vice President of Sales & Marketing, Mark Geiger, Who Lives with Hydrocephalus Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce the successful first implant of the Company’s...
-
7-year-old Boy Managing His Hydrocephalus with ReFlow Ventricular System “Gen 1” Featured on Charleston’s ABC News 4
After struggling to conceive a child for what felt like ages, Miranda of Moncks County, South Carolina finally fell pregnant - a miracle that quickly turned into horror when she delivered at 24 weeks in late 2015. At just 1 pound and 12 ounces, her son, Sutton, arrived with life-threatening health issues, including hydrocephalus - a neurological disorder caused by an abnormal buildup of cerebrospinal fluid in the brain that affects more than one million Americans.
-
FARCO-PHARMA initiates sales in the U.S.
The U.S. Food and Drug Administration recently completed its regulatory inspection of the production site in Berlin and issued FARCO-PHARMA approval for the marketing of a sterile lubricant in disposable syringes in the United States. FARCO-PHARMA has been producing and selling the sterile catheter lubricant under the brand name GLYDO® on the U.S. market since October 2014. Medicinal products for the U.S. market are manufactured at the same production site and conform to the same high quality standards as...
-
1st Patient treated with Vetex Thrombectomy Catheter
Vetex™ Medical Ltd., an innovator in deep vein thrombosis (DVT) treatment, announced it’s first patient on December 18th, 2018, treated in the VETEX (Venous Thrombus Extraction) Study, a first-in-man, multicenter study of the Vetex™ Thrombectomy Catheter. The Vetex device is the first DVT device to combine rotational and grasping action to quickly and gently remove large volumes of stubborn wall-adherent clot in a single session, without use of thrombolytic drugs. The first patient was treated...
Customer comments
No comments were found for Galaxy Medical Releases ECLIPSE-AF Remapping Data at Stanford Biodesign Retreat and Update on System Interoperability. Be the first to comment!