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The making of indigenous vascular prosthesis
Madathipat Unnikrishnan1, Sidharth Viswanathan1, K Balasubramaniam2
1Division of Vascular Surgery, Department of Cardiovascular & Thoracic Surgery, Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvananthapuram, India.
The Indian Journal of Medical Research
|October 18, 2016
Summary
An indigenous polyester vascular graft, developed in India, demonstrated safety and efficacy comparable to imported Dacron grafts. This development offers a cost-effective solution for treating vascular diseases, improving patient access to essential medical devices.
Area of Science:
- Biomaterials Science
- Vascular Surgery
- Medical Device Development
Background:
- Rising incidence of vascular illnesses in India necessitates effective treatment options.
- Lifestyle diseases and demographic shifts contribute to increased vascular pathologies.
- Development of indigenous vascular prostheses is crucial for life and limb salvage.
Purpose of the Study:
- To develop an indigenous large-diameter vascular graft.
- To provide a cost-effective alternative to imported vascular prostheses.
- To address the growing burden of vascular diseases in India.
Main Methods:
- Seamless woven polyester (Polyethylene terephthalate) grafts were developed.
- In vivo studies in pigs and controlled clinical trials (Phase I and II) were conducted.
- Grafts were evaluated for biocompatibility, healing characteristics, and long-term performance.
Main Results:
- Polyester grafts proved non-toxic, non-haemolytic, and maintained quality.
- Excellent healing characteristics, including perigraft incorporation and neointima formation, were observed.
- Clinical trials showed excellent recovery with no mortality or device-related adverse events, confirmed by long-term follow-up.
Conclusions:
- The indigenously developed Chitra vascular graft is comparable to commercial Dacron grafts.
- The graft is ready for clinical use and offers an affordable option for patients.
- This innovation addresses the need for accessible vascular prostheses in India.
