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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211101005797/en/
Contact information
Julie Logan Sands, Jsands@revalvesolutions.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
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
Deciphera Presents 2-Year Efficacy and Safety Results from MOTION Phase 3 Study of ROMVIMZA ™ (vimseltinib) in Patients with Tenosynovial Giant Cell Tumor (TGCT) at the European Society for Medical Oncology Congress 202518.10.2025 14:00:00 EEST | Press release
Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”), today announced the two-year efficacy and safety results from its MOTION Phase 3 study of vimseltinib in patients with TGCT in cases where surgical removal of the tumor is not an option will be presented as a poster during the 2025 European Society for Medical Oncology Congress (ESMO), taking place October 17-21 in Berlin, Germany. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251018921529/en/ “These long-term Phase 3 MOTION results add to the established body of evidence supporting vimseltinib as a best-in-class treatment for TGCT,” said Matthew L. Sherman, M.D., Chief Medical Officer of Deciphera. “TGCT often causes debilitating pain, stiffness and impaired mobility and these results demonstrate the durable benefit that vimseltinib can offer patients.” Summary of Data and Findings from the 2-year results of the MOTION Phase
ProAmpac Acquires International Paper’s Bag Converting Operations17.10.2025 17:09:00 EEST | Press release
ProAmpac, a global leader in flexible packaging and material science, has acquired the bag converting operations of International Paper (“IP”), a global leader in sustainable packaging. The acquisition expands ProAmpac’s converting capabilities, further advancing the company’s Fiberization of Packaging® strategy and enhancing its ability to deliver customized bag solutions for the grocery, convenience store, and quick-service restaurant markets. “Global demand for reliable, recyclable paper packaging continues to grow rapidly amid evolving consumer expectations and market trends redefining recyclability,” stated Greg Tucker, ProAmpac founder, vice chairman, and chief executive officer. “ProAmpac’s acquisition of IP’s bag operation supports our Fiberization of Packaging initiatives, helping us better serve customers by extending our expertise in material science to the US west coast with additional capabilities and redundancies,” continued Tucker. “IP’s bag business is strong, being bui
Pimicotinib Treatment Demonstrates Deep and Durable Tumor Responses and Continued Improvements in Pain and Function for Patients with TGCT17.10.2025 17:00:00 EEST | Press release
Merck, a leading science and technology company, today announced the presentation of longer-term results from the global Phase 3 MANEUVER trial evaluating pimicotinib, an investigational colony stimulating factor-1 receptor (CSF-1R) inhibitor in development by Abbisko Therapeutics Co., Ltd., for the treatment of patients with tenosynovial giant cell tumor (TGCT). This latest analysis showed that, with a median follow-up of 14.3 months, the objective response rate (ORR) for people treated with pimicotinib from the beginning of the study increased considerably to 76.2% (95% CI: 63.8, 86.0) by blinded independent review committee (BICR) per RECIST v1.1, from 54% at Week 25. The study also showed continued clinically meaningful improvements in key secondary endpoints related to patient outcomes such as pain and function. The safety profile was consistent with previously reported data. The results are being presented today in the Sarcoma mini-oral session at the European Society for Medical
Vertex Announces Progress in Povetacicept Development Program and Presentation of New Data at American Society of Nephrology Kidney Week17.10.2025 16:04:00 EEST | Press release
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced several important updates across its development program for povetacicept (pove), an investigational recombinant fusion protein therapeutic and dual antagonist of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines. Pove has demonstrated best-in-class potential in IgA nephropathy (IgAN) and primary membranous nephropathy (pMN) and has pipeline-in-a-product potential across a range of B cell-mediated diseases. Pove is the only BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Next Steps for Pove Development In IgAN Following the announcement that the Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to pove for the treatment of IgAN, FDA recently granted a rolling review of the Biologics License Application (BLA) for pove for this indication. Vertex expects to submit the first module to FDA for potential accelerated approval before t
Qualcomm Announces Quarterly Cash Dividend17.10.2025 16:00:00 EEST | Press release
Qualcomm Incorporated (NASDAQ: QCOM) today announced a quarterly cash dividend of $0.89 per common share, payable on December 18, 2025, to stockholders of record at the close of business on December 4, 2025. About Qualcomm Qualcomm relentlessly innovates to deliver intelligent computing everywhere, helping the world tackle some of its most important challenges. Building on our 40 years of technology leadership in creating era-defining breakthroughs, we deliver a broad portfolio of solutions built with our leading-edge AI, high-performance, low-power computing, and unrivaled connectivity. Our Snapdragon® platforms power extraordinary consumer experiences, and our Qualcomm Dragonwing™ products empower businesses and industries to scale to new heights. Together with our ecosystem partners, we enable next-generation digital transformation to enrich lives, improve businesses, and advance societies. At Qualcomm, we are engineering human progress. Qualcomm Incorporated includes our licensing
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