CHENNAI: In a significant breakthrough, researchers at the Indian Institute of Technology, Madras (IIT-M) have indigenously developed Asia’s first ‘life-saving’ implant called SynkroScaff — A Tissue Engineered Bovine Pericardial Patch — for critical cardiovascular patients. Now, the technology, which has a global market, is being commercially exploited by a Chennai-based firm SynkroMax Biotech (SMBPL), for which a memorandum of understanding was signed last month.
The distinctive feature of the IIT-M pericardial patch (sack of buffalo’s heart) is that it has inherent properties of regeneration and integration in the body. While the existing ones used in India are processed using synthetic material and toxic chemicals, which can lead to calcification, the product IIT-M came up with uses biomaterial. Currently, India depends on imported surgical patches.
Soma Guhathakurta, IIT-M adjunct professor and director of SMBPL, said it had the potential to revolutionise the field of surgical patches with products designed and made in India. This has twin advantages. One, India’s dependence on imports will be eliminated and two, patients don’t have to undergo a second procedure to remove the sack after usage. None of the synthetic, homologous (human-derived) and xenogeneic (compatible animal-derived) patches have potential for growth and repair requiring re-operations.
Interestingly, development of SynkroScaff using indigenous technology originally sprouted out of Guhathakurta’s doctoral research in IIT-M in 2004, under the guidance of Venkatesh Balasubramanian, professor, Department of Engineering Design. She claims that the product has got versatile use to achieve anatomical correction of the heart and its blood vessels’ deformities and deficiencies. “Its applications are immense in cardiovascular and other surgical practices. We obtained the licence for the product in May this year. So far, 800 patches have been manufactured and over 12 surgeons are using them across India. Apollo Hospitals, Kauvery Hospital in Chennai and AIIMS in Delhi are using it. We have also enrolled for Central Medical Services Society (CMSS) recognition of the product. The feedback from doctors and patients has been encouraging, with a 100 per cent success rate,” she said, adding that the product is manufactured in a facility complying with drug applications and current good manufacturing practice (cGMP) guidelines.
Venkatesh Balasubramanian, who mentored Guhathakurta, said, “It is always a desire that the philosophical work done as a doctoral thesis is inventive and innovative. This was possible by an innovative processing of xenogeneic tissue for human usage. While the doctoral work won the best thesis award from Indian National Science Academy (INSA) in 2008, the true victory is when it is available as a surgical patch for the world, made in India. It is a pleasure that Soma Guhathakurtha and SMBPL are taking this technology to offer SynkroScaff, a product conceived, researched, designed, developed and made in India, for the world.” Balasubramanian said the cost of imported material — between `30,000 and `35,000 — would be slashed by half using India-made implants.
CV Seshadri, MD, SMBPL said, “This sack is harvested and processed with biomaterial for ten days followed by quality control parameters to ensure it is microbial free. In India, chemicals like glutaraldehyde or formaldehyde are used, which are toxic and harmful, causing post complications in patients; 12 of 13 have congenital heart defect. Most of them do not get proper treatment.”