Bioprosthetic heart valve (bovine pericardium based)

Intended end use : For replacement of diseased heart valve (mitral or aortic)

Product description : This is a stress-free internally mounted bioprosthetic heart valve made using processed bovine pericardium with proprietary anti-calcification treatment, Polyacetal stent and polyester fabric, designed for both mitral and aortic positions.

Novelty(please specify patents if any filed) :
1. Patent Title: Prevention of in vivo calcification in glutaraldehyde cross-linked pericardium through Magnesium chelation Application no. 201741038920 dated 1-11-2017
2. Design registration: A novel device for mounting pericardial leaflets internally in bio prosthetic valves. Mr. Chirathodi Vylappil Muraleedharan, Mr. Ranjith Gopinathan, Dr. Umashankar Payanam Ramachandran, Mr. Muhammed Shafeeq Ellikkottukurissi Yoosuf, Mrs Sumathy Patturaja Bhagyalekshmi , Mrs. Anila Puthiya Veettil

Current Development stage/ Evaluations done :
1. Preliminary Material qualification as per ISO 10993 (Poly acetal material, polyester fabric, polyester sutures and processed bovine pericardium)
2. Mechanical studies of processed bovine pericardium.
3. Stability studies of processed pericardium.
4. Sterility validation of liquid chemical sterilization.
5. In vivo calcification study in 60 days juvenile rat model, 6 months pig aortic patch and 6 months sheep orthotopic implantation model (as bioprosthetic heart valve).
6. Hydrodynamic performance (Steady Flow) tests as per ISO 5840:2
7. Accelerated durability studies (up to 200 M Cycles)
8. Test valve: POC animal studies in sheep for 6 months duration

Industry responsibility for technology transfer :
1. Scale-up production
2. Preclinical evaluation of device manufactured under ISO 13485
3. Regulatory clearances
4. Clinical trials

Deliverables from Institute :
1. Technology Transfer documents on material qualification, raw material processing, fabrication of heart valve, quality assurance.
2. Hand-holding of industry during the service life of the medical device.