The JenaValve Pericardial TAVR System is a Class III, investigational device undergoing clinical trials in the US and internationally. It is not approved for sale in any country.
Information for Healthcare Professionals about Jenavalve and our TAVR technology.
JenaValve Technology Inc. develops and manufactures minimally invasive Transcatheter Aortic Valve Replacement Systems designed for patients for the treatment of aortic valve disease; specifically, symptomatic, severe aortic stenosis and aortic regurgitation. Building on the Company’s original CE Marked porcine root system (the JenaValve™), our next generation JenaValve Pericardial TAVR System is currently in clinical trials with both transfemoral and transapical delivery systems.
The JenaValve Pericardial TAVR System was designed to address clinical needs of both aortic stenosis and aortic regurgitation, with the following feature set in mind:
|Design Intent||Design Feature|
Facilitate precise implant positioning in the aortic annulus
|Three radiopaque locators facilitate fluoroscopy-guided positioning into the native valve cusps|
Enable correct aortic anatomical positioning and sealing with annulus independent of the extent of native valve calcification.
|Locator engagement with the native valve cusps is intended to anatomically mitigate the risk of low placement into the LVOT.|
Mitigate risk of low placement into the LVOT, which is associated with heart block and new permanent pacemaker implant.
|Prosthesis is fixed onto the native leaflets (like a paperclip) Fixation is independent of extent of native valve calcification Clipping is intended to provide additional stability|
Provide a durable prosthetic aortic valve implant
|Self-expanding nitinol stent having flexible commissure posts, and trileaflet pericardial valve with proprietary tissue processing technology are intended to support the long-term durability of the implant.|
Mitigate risk of coronary artery obstruction
|Low-profile implant design, void of stent mesh in area of coronary ostia, is intended to mitigate the risk of coronary obstruction.|
Enable Procedural Flexibility
|Prosthesis continues to be repositionable after locator release and prior to stent deployment.|
Enable Interventionist Ease of Use
|Catheter-based, hydrophilically coated delivery systems compatible with either transfemoral or transapical approaches. Intuitive, controlled valve deployment steps are intended to enable ease of use and predictability of procedural outcomes.|
EU/International: Exclusively for Investigational Use.
US: CAUTION: Investigational Device. Limited by federal (or United States) law to investigational use only.