Clinical Expertise and Knowhow to Introduce New Therapies and Drive Access and Quality
Medtronic is committed to pioneering the practice of Evidence Based Medicine in the medical device industry in India. Facilitating patient access to life-saving and supportive device therapies requires world-class clinical and economic outcomes evidence. Medtronic conducts and promotes clinical research with the following objectives:
Over the years, Clinical Research team in Medtronic has engaged in approximately 25 clinical studies across 100 sites in India and Bangladesh with the aim of generating evidence and overcoming barriers to therapy access. Medtronic’s global studies have included significant participation from the Indian Subcontinent. This has led to increased understanding of the variations in patient cohorts and outcomes in different regions of the world. Studies like IMPROVE-Brady1 and IMPROVE-SCA2 (Sudden Cardiac Arrest) saw significant regional data being added to the overall global pool of patient data.
The Micra Transcatheter Pacing Global Clinical Trial3,4 was another trial where India’s participation not only led to approval of the novel leadless pacemaker, Micra for marketing in India, but also contributed to the increasing global body of evidence regarding outcomes with this new technology. Medtronic also studied clinical outcomes in Indian patients with Type II diabetes undergoing continuous glucose monitoring, for the purpose of optimizing therapeutic interventions and improving glycemic control. The study findings were published in Journal of The Association of Physicians of India.5
The PANARM-HF study6 was a landmark study undertaken by Medtronic in Indian patients with cardiac arrhythmia or heart failure. The goal was to characterize patient demographics, enhance awareness of guidelines for diagnosis and referral of these patients among the consulting physician community, and analyze various barriers to therapy access that the patients encounter. The STAR registry7 was another first-of-its-kind study looking into the medical management and diagnostic testing of patients with stable angina. The findings of PANARM-HF and STAR registries highlight the importance of conducting registries to collect such real-world information which has great potential in transforming healthcare policies in India.
The Medtronic External Research Program (ERP) supports a global network of investigator-initiated research projects in the spirit of advancing medical and scientific knowledge. Focusing on the discovery, development, and cultivation of cutting-edge therapies and diagnostics, the program fosters investigative research with the goal of improving the quality of patient care and clinical outcomes.. Medtronic has several more innovative technologies which can benefit countless patient lives in India. Medtronic works with the regulatory authority in India to launch new innovative technologies through demonstration of safety and performance in the local population.
Overall, Medtronic is expanding its efforts to create therapy awareness and adoption through widespread dissemination of safety, performance, efficacy and economic value evidence across the physician and patient community.
1 C. Narasimhan, A. K. Parida, A. Naik, R. Sethi, S. Chandra, Y. Kothari, F. T. Malik, U. Pandurangi, K. N. Khan, K. Lindborg, S. Sahu, J. Lande and R. Radhakrishnan, "Under-utilization of pacemaker therapy for sinus node dysfunction - real world data from South Asia," in 8th Asia Pacific Heart Rhythm Society Scientific Sessions, Melbourne, 2015.
2 B. Singh, A. Hussin, D. Huang, C. Ching, D. A. Rodriguez, Y. Kim, Y. Liu, A. R. Chasnoits, J. Monteiro, K. Muckala and S. Zhang, "Studying ICD therapy where ICDs are underutilized: implant rates higher than expected in the IMPROVE SCA trial," in 9th Asia Pacific Heart Rhythm Society Scientific Session, Seoul, 2016.
3 J. Piccini, K. Stromberg, K. Jackson, V. Laager, G. Duray, M. El-Chami, C. Ellis, J. Hummel, D. Jones, R. Kowal, C. Narasimhan, R. Omar, P. Ritter, P. Roberts, K. Soejima, S. Zhang, D. Reynolds and M. T. P. S. Group, "Long-term outcomes in leadless Micra transcatheter pacemakers with elevated thresholds at implantation: Results from the Micra TPS Global Clinical Trial," Heart Rhythm, Vols. S1547-5271, no. 17, pp. 30074-7, 2017.
4 G. Duray, P. Ritter, M. El-Chami, C. Narasimhan, R. Omar, J. Tolosana, S. Zhang, K. Soejima, C. Steinwender, L. Rapallini, A. Cicic, D. Fagan, S. Liu, D. Reynolds and M. T. P. S. Group, "Long-term performance of a transcatheter pacing system: 12-Month results from the Micra Transcatheter Pacing Study," Heart Rhythm, Vols. S1547-5271, no. 17, pp. 30146-7, 2017.
5 V. Mohan, S. Jain, J. Kesavadev, M. Chawla, A. Mutha, V. Viswanathan, B. Saboo, R. Kovil, A. Mithal, D. Punatar and J. Shin, "Use of retrospective continuous glucose monitoring for optimizing management of Type 2 diabetes in India," J Assoc Physicians India, vol. 64, no. 4, pp. 16-21, 2016.
6 A. Vora, A. Naik, Y. Lokhandwala, A. Chopra, J. Varma, G. Wander, A. Jaswal, V. Srikanthan, B. Singh, D. Kahali, A. Gupta, A. Mantri, A. Mishra, U. Pandurangi, D. Ghosh, J. Makkar, S. Sahu and R. Radhakrishnan, "Profiling cardiac arrhythmia and heart failure patients in India: The Pan-arrhythmia and Heart Failure Observational Study," Indian Heart J, vol. xx, no. xx, p. xx, 2017.
7 D. Pahlajani, U. Kaul, A. Mishra, A. Mullasari, J. Sawhney, R. Dargad, K. Mehta, S. Brar, R. Radhakrishnan, D. McMahon, S. Ibrahim, H. Sachanandani and N. Sinha, "Medical management and diagnostic testing among stable angina patients in India: The STable Angina obseRvational (STAR) registry.," J Assoc Physicians India, vol. 63, no. 9, pp. 20-6, 2015.