JenaValve Technology, Inc.
JenaValve is a global medical device company dedicated to supporting physicians with innovative technology for treating structural heart disease, especially severe aortic regurgitation and stenosis. They develop transcatheter heart valve systems, including the Trilogy Heart Valve System, which is designed for high surgical risk patients and has received CE Mark approval. The company is focused on advancing minimally invasive treatments and is involved in clinical trials and regulatory approvals, including FDA submissions for the U.S. market.
Industries
Nr. of Employees
medium (51-250)
Patents
Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame
US-12318281-B2
View DetailsStent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US-12232957-B2
View DetailsHeart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath
US-12121461-B2
View DetailsProsthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
US-11589981-B2
View Details
Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame
US-12318281-B2
View DetailsStent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient
US-12232957-B2
View DetailsHeart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath
US-12121461-B2
View DetailsProsthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent
US-11589981-B2
View DetailsProducts
Transcatheter heart valve system (transfemoral THV system)
A transfemoral transcatheter heart valve system consisting of a self-expanding metal stent frame and biological tissue valve, delivered via a transfemoral catheter and designed for implantation with locator-based anchoring and anatomical alignment to treat severe aortic regurgitation and aortic stenosis in high surgical risk patients.
Transcatheter heart valve system (transfemoral THV system)
A transfemoral transcatheter heart valve system consisting of a self-expanding metal stent frame and biological tissue valve, delivered via a transfemoral catheter and designed for implantation with locator-based anchoring and anatomical alignment to treat severe aortic regurgitation and aortic stenosis in high surgical risk patients.
Services
Sponsor and operate pivotal IDE trials designed to assess safety and effectiveness of transcatheter heart valve systems and to support regulatory submissions.
Manufacture and supply of implantable transcatheter heart valve systems for commercial use in approved regions, including expansion planning to increase global manufacturing capacity.
On-site and proctored support for physicians during initial commercial and investigational use of transcatheter valve procedures to ensure proper implantation technique and device utilization.
Engagement with regulatory authorities and preparation of submissions to obtain approvals and designations in target jurisdictions.
Collaborative programs to generate real-world epidemiology and outcomes data, including use of AI-driven analytics to study prevalence, treatment patterns, and outcomes.
Sponsor and operate pivotal IDE trials designed to assess safety and effectiveness of transcatheter heart valve systems and to support regulatory submissions.
Manufacture and supply of implantable transcatheter heart valve systems for commercial use in approved regions, including expansion planning to increase global manufacturing capacity.
On-site and proctored support for physicians during initial commercial and investigational use of transcatheter valve procedures to ensure proper implantation technique and device utilization.
Engagement with regulatory authorities and preparation of submissions to obtain approvals and designations in target jurisdictions.
Collaborative programs to generate real-world epidemiology and outcomes data, including use of AI-driven analytics to study prevalence, treatment patterns, and outcomes.
Expertise Areas
- Transcatheter aortic valve replacement (TAVR/THV) device development
- Structural heart disease clinical trial management (pivotal IDE/PMA)
- Regulatory strategy and submissions (CE Mark, FDA Breakthrough/IDE/PMA)
- Bioprosthetic valve materials and processing
Key Technologies
- Transcatheter heart valve systems (TAVR/THV)
- Locator-based anchoring mechanisms for non-calcified anatomy
- Self-expanding nitinol stent frames
- Porcine pericardial tissue valve processing