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
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
Bureau Veritas Strengthens Global Sustainable Finance Capabilities with Expanded Climate Bonds Approved Verifier Status26.3.2026 09:30:00 EET | Press release
Bureau Veritas, a global leader in Testing, Inspection, and Certification services (TIC), is pleased to announce the expansion of its geographical scope as an Approved Verifier under the Climate Bonds Standard and Certification Scheme. Additional offices in China, Japan, India, and France are now formally listed in the Climate Bonds Verifiers Directory. This expansion builds on Bureau Veritas’ established role since the approval of its Brazilian office in 2020, further enhancing its ability to support issuers with high-quality, independent verification services across key markets. “Our expanded presence as an Approved Verifier under the Climate Bonds Standard reinforces Bureau Veritas’ commitment to advancing credible, high‑integrity sustainable finance”, said Marc Roussel, Executive Vice President, Urbanization and Assurance at Bureau Veritas. “With verifier capabilities available across key markets, we continue to deliver local expertise with global assurance standards; boosting mark
Invivoscribe ® Expands IVDR Portfolio with IdentiClone ® Dx IGH Assay Certification26.3.2026 07:13:00 EET | Press release
Invivoscribe, a global leader in precision diagnostics and measurable residual disease (MRD) testing, is proud to announce that its IdentiClone Dx IGH Assay has received In Vitro Diagnostic Regulation (IVDR) 2017/746 Class C certification in the European Union (EU). Commercial availability of the IVDR-certified assay is anticipated by early April 2026. The IVDR replaces the former In Vitro Diagnostics Directive (IVDD), introducing significantly more stringent requirements for clinical evidence, performance evaluation, traceability, and post-market surveillance. Under IVDR, in vitro diagnostic devices are classified according to risk from Class A (lowest risk) to Class D (highest risk). Class C devices, such as IdentiClone Dx IGH, are considered high-risk tests that play a critical role in disease diagnosis and patient management. BSI (Netherlands), an EU-designated Notified Body, granted CE certification for the IdentiClone Dx IGH Assay following an independent conformity assessment un
Dominican Republic Drives Modernization of Electronic Passports Under the Leadership of the Thales - MIDAS Consortium26.3.2026 00:22:00 EET | Press release
The Presidency of the Dominican Republic, through the General Directorate of Passports, issued the country’s first electronic passport as part of its strategy to modernize and strengthen national security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324368065/en/ Passport of the Dominican Republic The new document was developed in partnership with Thales, world leader in advanced technologies for the Defense, Aerospace, Cybersecurity, and Digital sectors, and Midas Dominicana, a Dominican business group specializing in the comprehensive management of technology projects in the region. Together, both companies will guarantee the delivery of a passport that is more secure, reliable, and compliant with international standards. The project introduces and personalizes the country’s electronic passports, using advanced technologies to ensure the authenticity and protection of each document, while strengthening the national i
Dominican Republic Drives Modernization of Electronic Passports Under the Leadership of the Thales - MIDAS Consortium26.3.2026 00:22:00 EET | Press release
The Presidency of the Dominican Republic, through the General Directorate of Passports, issued the country’s first electronic passport as part of its strategy to modernize and strengthen national security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324368065/en/ Passport of the Dominican Republic The new document was developed in partnership with Thales, world leader in advanced technologies for the Defense, Aerospace, Cybersecurity, and Digital sectors, and Midas Dominicana, a Dominican business group specializing in the comprehensive management of technology projects in the region. Together, both companies will guarantee the delivery of a passport that is more secure, reliable, and compliant with international standards. The project introduces and personalizes the country’s electronic passports, using advanced technologies to ensure the authenticity and protection of each document, while strengthening the national i
Dominican Republic Drives Modernization of Electronic Passports Under the Leadership of the Thales - MIDAS Consortium26.3.2026 00:22:00 EET | Press release
The Presidency of the Dominican Republic, through the General Directorate of Passports, issued the country’s first electronic passport as part of its strategy to modernize and strengthen national security. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260324368065/en/ Passport of the Dominican Republic The new document was developed in partnership with Thales, world leader in advanced technologies for the Defense, Aerospace, Cybersecurity, and Digital sectors, and Midas Dominicana, a Dominican business group specializing in the comprehensive management of technology projects in the region. Together, both companies will guarantee the delivery of a passport that is more secure, reliable, and compliant with international standards. The project introduces and personalizes the country’s electronic passports, using advanced technologies to ensure the authenticity and protection of each document, while strengthening the national i
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