The medical device industry is driven by technological developments. A recent example is Medtronic’s leadless pacemaker, Micra. It earned CE approval in 2015 and has enjoyed a warm reception from electrophysiologists.
Micra is one-tenth size of a traditional pacemaker and eliminates lead issues—like infection, lead dislodgement and fracture—important and not uncommon issues that have serious effects on patients.
India has tremendous potential to have a huge customer base for this product because the country has a large aging population and an increasing prevalence of cardiovascular disease. In fact, India is now among top three countries with high diabetic population and the diabetic population has risen from 11.9 million in 1980 to 64.5 million in the country. Diabetes is associated with cardiovascular disease which can require pacemaker treatment.
Micra implantation does not require surgery and is implanted through a catheter. Considering India’s low number of specialist physicians, the ease of implantation would make the device even more preferable in the country. Additionally, since it is a transcatheter procedure, less lab infrastructure is needed to implant it compared to a traditional pacemaker.
What are some limitations to this product’s uptake in India?
- Micra has a price premium which is anticipated to be significantly higher than a traditional pacemaker. India is a price sensitive market. Most patients are not covered by any medical insurance, which means pacemaker implantation is a mostly out-of-pocket expense. In that case, a device with its superior technological advantages faces a challenge in gaining popularity and thus capturing market share.
- On the other hand the recent reimbursement plans by the Indian government—including revision of the reimbursement ceilings for medical devices—would help reduce out-of-pocket expenses. Of course, other manufacturers will also get into the foray offering their own leadless device, driving down prices. All this supports the adoption of leadless pacemakers in India.
- Secondly, Micra is a single chamber pacemaker which only caters to patients with a requirement of single chamber pacing. Dual chamber pacemakers pace both chambers of heart (the right atrium and right ventricle) and the transition from using single to dual chamber is happening rapidly in India. As more patients are treated with dual chamber pacing this reduces the potential demand for the single chamber pacing Micra device.
However, the transition towards the dual chamber pacemaker will be strongly mitigated by the ease of implantation of single chamber pacemaker. Considering the less developed training of electrophysiologists in the country, single chamber pacing will still strive. This ultimately supports the uptake of Micra.
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