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Introducing the Perceval Sutureless Surgical Valve for MICS and Complex Procedures.
Perceval's design was made for Minimally Invasive Cardiac Surgery. It's an innovative, sutureless and collapsible aortic bioprosthesis that allows for shorter procedures and reduced physiologic impact during surgery.4
Safe and reliable solution AVR with 10 years of experience:
- Excellent hemodynamics8
- Excellent clinical outcomes8
PERCEVAL
References
1. Glauber M. et al. Innovations 2016; 11(3):165-173
2. Di Eusanio M et. al. Ann Cardiothoracic Surg. 2015; 4(2):131-139
3. Gilmanov D et al. Ann Thorac Surg. 2013;96:2101-8
4. Ranucci M et al. J Heart Valve Dis. 2012 Nov.21(6):732-9
5. Phan K. et al. Ann Cardiothorac Surg. 2015 Mar; 4(2): 100-111
6. Late Breaking Trial LB4 - Suri R. et al. AATS 2017
7. Barnhart et al. J Thorac Cardiovasc Surg. 2016: Volume 153 (2): 241-251
8. Minami et al. Surgery Today 2017 Apr 6. doi: 10.1007/s00595-017-1516-8
Learn More About Perceval
For a copy of the IFU, please contact HeartValves.US@LivaNova.com
© LivaNova 2018
Introducing the Perceval Sutureless Surgical Valve for MICS and Complex Procedures.
Aortic Pericardial Heart Valve
®
Truly Sutureless
Self-expanding sutureless design reduces operative time, trauma and manipulation of aortic structures.1
Minimized Incision
Reduced incision size and less surgical trauma during implantation due to collapsible profile.2,3
Thanks to its unique collapsible profile, Perceval is the smallest surgical valve during implantation on the market to date, hence, reduced incision size and less surgical trauma.2,3
LivaNova PERCEVAL
Overall valve dimension during implantation
PERCEVAL size M
Approximately 20 mm
INTUITY size 23
Approximately 28 mm
Edwards INTUITY ELITE
Overall valve dimension during implantation8
Shorter Procedure
Shorter procedure minimizes blood transfusion and complications regardless of surgical approach.4,5
Eliminating the drawback of long procedure times in MICS: Minimally invasive aortic procedures are generally known to increase procedure times versus sternotomy.1
- The PERCEVAL IDE US trial showed that PERCEVAL reduces the impact of MICS on procedure times.6 Cross clamp times in isolated AVR for PERCEVAL were only 5.9% longer for MICS than full sternotomy.
- The US Transform trial7 study showed that the INTUITY Rapid Deployment valve had 30% longer cross clamp times for MICS than full sternotomy.
LivaNova PERCEVAL
Edwards INTUITY ELITE
INTUITY10 Transform
PERCEVAL IDE6
IM-01982 A
Indication for Use:
The Perceval bioprosthesis is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
Summary of Risks:
The risks or potential adverse events associated with cardiac valve replacement with a bioprosthesis include, but may not be limited to: cardiac arrhythmias, death, endocarditis, heart failure, hemorrhage, intravalvular and/or paravalvular leak, stroke or any related neurologic disorders, structural valve deterioration, reoperation and explant. Beyond the previously mentioned adverse events, specific events related to the implant of the Perceval prosthesis may include, but not be limited to dislodgment and/or migration of the prosthesis. Please refer to the product Instructions for Use (IFU) for detailed information on warnings, precautions, and potential adverse events. For a copy of the IFU, please contact: HeartValves.US@LivaNova.com