Business Wire

WA-REVALVE-SOLUTIONS

Share
ReValve Solutions, Inc. Announces Successful First Human Use of the Transeptal Mitral Valve Replacement

ReValve Solutions, Inc., an innovator in the field of transcatheter structural heart replacement and repair, announced today it has successfully completed the first human use of its transcatheter, Palmetto System for mitral valve replacement. The patient was successfully treated who suffered from severe mitral valve regurgitation and heart failure. The transfemoral-transseptal procedure was performed at the Italian Hospital in Asuncion, Paraguay by Dr. Charles Davidson, (Medical Director, Bluhm Cardiovascular Institute) and Dr. Edris Aman, (Assistant Clinical Professor of Cardiovascular Medicine at the University of California, Davis Medicine Center specialized in Multimodality Imaging).

"The complexity of mitral valve pathology creates challenges for transcatheter therapies to treat effectively. The first in human experience with this innovative technology shows promise for patients with advanced mitral valve regurgitation,” said Charles Davidson, MD.

"The features of the Palmetto System allow for transseptal mitral valve replacement in native mitral regurgitation. This case highlights the potential for this technology, which is another step forward for transseptal mitral valve replacement,” said Edris Aman, MD.

“The case is a major step forward in Re-Imaging the treatment of structural heart disease. Our unique portfolio of technologies is based on our understanding of the evolution of disease and the need to provide for ongoing management of valvular heart disease. I am extremely proud of our team’s focus and dedication,” said Julie Logan Sands, CEO and Founder of ReValve Solutions

The Palmetto System is a complete mitral valve replacement. It is delivered via transfemoral-transeptal procedure. The system is design to avoid any disturbance to the left-ventricular outflow tract and if needed will allow for future valve replacement without compromising the orifice area. Preserving options for the physician and patient is an essential part of the solution to structure heart treatment.

About ReValve Solutions, Inc.

ReValve Solutions, Inc. (www.revalvesolutions.com ) is based in, Washington with the mission of delivering innovative solutions to structure heart disease through catheter-based procedures. Solutions that are tailored to the needs of the patient. For more information visit www.ReValveSolutions.com

Related Links http://www.revalvesolutions.com

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Hemato-Oncology Trials: AOP Health Presents New Results at Top Congress ASH7.12.2025 17:00:00 CET | Press release

AOP Health continues to advance its clinical research program in myeloproliferative neoplasms, a special group of rare blood cancers. The company, specialized in rare diseases, presented the results of two scientific investigations at the 67th American Society of Hematology Association (ASH) Annual Meeting 2025 held in Orlando, FL, USA. The results provide new insights in treatment strategies. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251207587915/en/ Dr. Martin Steinhart, CEO AOP Health; Photo credit: AOP Health/Studio Koekart ROP-ET and BESREMI PASS One of the clinical studies, ROP-ET, examined the use of ropeginterferon alfa-2b in people with essential thrombocythemia (ET), a disease in which the body produces too many platelets. The trial, a prospective, multicenter, single-arm phase III study, investigated the safety and efficacy of ropeginterferon alfa-2b in ET patients unable to receive available cytoreductive th

CoMotion GLOBAL 2025 Launches in Riyadh: Global Mobility Leaders Unite in Saudi Capital to Chart Urban Future7.12.2025 13:00:00 CET | Press release

Summit debuts Mayors in Motion initiative and CoMotion Urban Visionary Distinction as Riyadh showcases its rise as global mobility testbed Riyadh is rapidly becoming one of the world's most ambitious urban mobility laboratories, where next-generation technologies move from blueprint to real-world deployment on city streets at unprecedented scale. CoMotion GLOBAL 2025, the world's most influential gathering of urban mobility leaders, opens today in Riyadh for a three-day summit bringing together innovators from Africa, Asia, Europe, the Americas, and the Middle East. Running December 7-9, the event will explore how electrification, autonomy, AI-enabled transport, and giga-project urbanism are reshaping cities worldwide. The summit will spotlight everything from high-performance EVs and breakthrough autonomous fleets to emerging-market transport solutions and new mobility models, demonstrating how the Kingdom is opening new pathways for global mobility leadership. Strategic Partnerships

Deciphera Announces Oral Presentation of Positive Topline Results from Phase 2a Study of Sapablursen in Polycythemia Vera at the 67th American Society of Hematology (ASH) Annual Meeting6.12.2025 15:30:00 CET | Press release

Results from Phase 2a IMPRSSION study demonstrate sapablursen significantly reduced phlebotomy rate, controlled hematocrit and increased serum hepcidin Sapablursen was generally safe and well tolerated Results support further development of sapablursen in a Phase 3 study Deciphera Pharmaceuticals, a member of Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the oral presentation of positive results from the Phase 2a IMPRSSION study of sapablursen in patients with polycythemia vera (PV) at the 67th American Society of Hematology (ASH) Annual Meeting, taking place December 6-9, 2025, in Orlando, FL. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251206361611/en/ The results were presented by Ionis Pharmaceuticals, who discovered and developed sapablursen and conducted the IMPRSSION study. In March 2025, Ionis and Ono entered into a license agreement in which On

Protagonist and Takeda Present Longer-Term Data at ASH 2025 Showing Rusfertide Delivers Durable Response and Hematocrit Control in Polycythemia Vera6.12.2025 15:30:00 CET | Press release

52-Week Results from the Phase 3 VERIFY Study of Rusfertide Demonstrated Sustained Hematocrit Control and Response, Defined by Absence of Phlebotomy Eligibility, with No New Safety SignalsThese Data Build on Positive 32-Week Primary Analysis from VERIFY, Which Met its Primary Efficacy Endpoint and All Four Key Secondary EndpointsPatients Crossing Over from Placebo to Rusfertide at 32 Weeks Achieved a Similar Response Rate to Those Initially Randomized to Rusfertide, with 77.9% Achieving Absence of Phlebotomy Eligibility Between Weeks 40-52Four-Year Results from the Combined REVIVE and Long-Term Extension THRIVE Study Demonstrated a 13-Fold Reduction in Annual Rate of Phlebotomies from Baseline Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announce that new 52-week results from the pivotal Phase 3 VERIFY study evaluating rusfertide in patients with polycythemia vera (PV) will be presented in an oral presentation at the 67th American Society

Vertex Presents New Data on CASGEVY®, Including First-Ever Data in Children Ages 5-11 Years, at the American Society of Hematology Annual Meeting and Announces Plan for Global Regulatory Submissions6.12.2025 13:01:00 CET | Press release

- Data from pivotal studies of CASGEVY in children ages 5-11 years with severe sickle cell disease or transfusion-dependent beta thalassemia demonstrates the transformative potential of the therapy in younger patients -- Efficacy and safety data in children 5-11 years are consistent with the durable and positive benefit/risk profile established from clinical studies in patients 12 years of age and older -- Vertex expects to initiate global regulatory submissions for CASGEVY in children 5-11 years in 1H 2026 - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data from multiple studies demonstrating the clinical benefits of CASGEVY® (exagamglogene autotemcel) in people ages 5 years and older living with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT). The results, including the first presentation of clinical data from pivotal studies in children ages 5-11 years, and longer-term data from the pivotal studies of people with severe SCD and

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye