Business Wire

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

1.11.2021 20:18:00 EET | Business Wire | Press release

Share

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.

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

Galderma’s Relfydess™ (relabotulinumtoxinA) Receives Approval in China for Frown Lines23.10.2026 08:00:00 EEST | Press release

Galderma (SIX: GALD) today announced that the Chinese NMPA has approved Relfydess for the temporary improvement of moderate-to-severe frown lines in adults, marking a significant expansion of the company’s Injectable Aesthetics portfolio in China – one of the world's largest and fastest-growing aesthetics markets.8,9 This approval follows successful authorizations and launches of Relfydess in more than 35 markets worldwide. Relfydess is the first and only ready-to-use liquid neuromodulator developed with PEARL Technology, designed to deliver a highly active, innovative, complex-free molecule that addresses the real needs of patients and healthcare professionals.1,2,4,5 It is optimized for simple volumetric dosing, without reconstitution, to increase ease-of-use and help ensure consistent dose/volume every time.1,10 At a time whenpatients and healthcare professionals are increasingly seeking high-performance neuromodulators that rapidly deliver long-lasting, natural-looking outcomes, Re

Mundipharma Announces Further Phase III ReSPECT Results Presented as a Late-Breaking Oral Presentation at IDWeek 202622.10.2026 20:03:00 EEST | Press release

Today Mundipharma announced additional results from the global Phase III ReSPECT clinical trial evaluating REZZAYO®(rezafungin acetate) for prophylaxis of invasive fungal diseases (IFDs) in adult patients undergoing allogeneic haematopoietic stem cell transplantation (allo-HSCT). The Phase III findings were presented today as a late-breaking oral presentation at IDWeek 2026. The presentation provides additional detail following the top line ReSPECT results announced in April 2026, including further endpoint analyses, the components contributing to fungal-free survival (FFS), pre-specified sensitivity analyses and detailed safety outcomes. The additional analyses were consistent with the previously announced topline findings. ReSPECT was a global, multicentre, randomised, double-blind Phase III study in which 402 patients were randomised to rezafungin and 200 to the standard antimicrobial regimen. As previously announced, the study met its primary endpoint, demonstrating non-inferiority

Tigo Energy Improves Installer Choice via Fronius Compatibility with TS4 Product Line22.10.2026 19:02:00 EEST | Press release

Tigo Energy, Inc. (NASDAQ: TYGO) (“Tigo” or “Company”), a leading provider of intelligent solar and energy software solutions, today announced a manufacturer declaration of compatibility from Fronius International GmbH, documenting compatibility between Tigo Flex MLPE products and multiple Fronius inverter families. The letter covers Tigo TS4-A-F, TS4-A-2F, TS4-A-O, and TS4-X-O products and the Fronius Primo GEN24, Primo GEN24 208-240, Symo GEN24, Verto, Tauro, and Tauro ECO inverter families, when configured according to the requirements specified by Fronius and Tigo. Building on established compatibility in Europe, the declaration extends manufacturer-confirmed compatibility to markets worldwide, including the United States and Canada, giving solar professionals greater flexibility to design high-quality systems using manufacturer-confirmed technology combinations. Fronius develops solar technologies and solutions for residential, commercial, and large-scale applications, with a port

Saudi Maritime & Logistics Congress Highlights Maritime Sector Integration and Opportunities for Trade and Investment Growth in the Kingdom22.10.2026 17:52:00 EEST | Press release

The Saudi Maritime & Logistics Congress highlighted Saudi Arabia’s role in supporting the continuity of trade flows and strengthening supply chain resilience as it opened at Jeddah Superdome, bringing together representatives of government entities, maritime transport and logistics leaders, and the business community. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261022362613/en/ The Congress takes place as rapid changes in trade and shipping prompt companies to reassess transport routes and operational and investment choices. It provides a platform for dialogue among stakeholders to explore opportunities for cooperation and strengthen integration between ports and maritime, land transport and logistics services, supporting operational efficiency and supply chain reliability. In his opening address, His Excellency Eng. Fawaz Alsahli, President of the Transport General Authority in Saudi Arabia, emphasised that the Kingdom’s

Ministerial Roundtable Discusses Mobilising Green Investments for a Resilient and Inclusive Global Economy22.10.2026 17:49:00 EEST | Press release

HE Saeed Mohammed Al Tayer, Chairman of the World Green Economy Organization, opened the Ministerial Roundtable titled "From Ambition to Bankable Action-Mobilising Green Investments for a Resilient and Inclusive Global Economy," during the 12th World Green Economy Summit (WGES), held on 21-22 October 2026 at the Dubai World Trade Centre under the theme "From Success to Scale: Showcasing the Green Economy." This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261022803264/en/ Ministerial Roundtable Discusses Mobilising Green Investments for a Resilient and Inclusive Global Economy (Photo: AETOSWire) The session was attended by HE Dr. Amna bint Abdullah Al Dahak, Minister of Climate Change and Environment, the United Arab Emirates; HE Aliou Gori Diouf, Minister of Environment and Ecological Transition, Senegal; HE Balarabe Abbas Lawal, Minister of Environment, Nigeria; HE Steven Victor, Minister of Agriculture, Fisheries, and the En

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