Thursday, 5 March 2015

The TTK Chitra Heart Valve: A High Quality Prosthesis for $350

A Successful Class III Medical Device From India

The TTK Chitra Heart Valve is a model disruptive medtech innovation for India and the world. Developed painstakingly over 12 years at the Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Trivandrum, India, the device is now licensed for manufacture and marketing to TTK Healthcare in Chennai. It has nearly 90,000 implantations to date, and sold over 10,000 in FY 2011-12 alone. Additionally, TTK now exports the device to all neighboring countries, as well as South Africa. Overall, about 250 medical centers and 300 surgeons were using the TTK Chitra Heart Valve as of 2014.

Importantly, the TTK Chitra Heart Valve is a Class III medical device, a status almost unique among indigenous Indian medtech. India still imports the majority of its medical devices across all classifications, but very nearly all Class III medical devices are still imported from abroad. The Chitra valve definitively shows that India has the technical capability to produce extremely high quality devices for even the most sensitive medical applications. 


The TTK Chitra Heart Valve Story

The Chitra story begins with a glaring clinical and social need in India, where the incidence of Rheumatic Fever and Rheumatic Heart Disease (RHD) remains high among children. An estimated 2-2.5 million patients suffer from RHD in India, and this is the leading cause of structural heart valve damage in the country. This is an important difference between India and the U.S., where the leading cause of cardiac valvular stenosis or regurgitation (the two symptoms indicating structural damage and the need for replacement surgery) is Degenerative Heart Disease, a potential condition of old age.

For decades, India relied on imports of expensive artificial valve replacements to meet domestic need, but many families whose children developed RHD were also among the poorest in India, and could not afford even the heavily discounted price tags of imported valves, which hovered around $1,200 each. And so their children died, or lived drastically shortened and unhealthy lives.

Chitra Heart Valve
The Chitra Heart Valve
The Chitra valve project sought to address this significant public health challenge by creating an affordable, high quality artificial heart valve for India. The project succeeded. Not only does it feature genuine design and material science innovations around in-vitro noise reduction, blood flow resistance reduction, and durability, but the valve also uses the highest quality materials and manufacturing for the frame, occluder, and sewing ring components. One would think such quality and a 12-year product development cycle with extensive clinical trials would raise the price considerably, but TTK Healthcare sells each valve for just $315-$400, a price range it has maintained since 1995, even in the face of considerable inflation in India. Facing such disruption from an indigenous entrant, the MNCs all lowered their prices for replacement valves to parity with Chitra's as a way to stay in the market.

This cost reduction story is compelling, but there's an important caveat. The SCTIMST is a public institution, so the product development costs over 12 years were therefore likely funded by grants from the Biotechnology Industry Research Assistance Council of India and other public funds. Depending on the terms of investment and licensure to TTK, the Chitra valve's public genesis may have obviated the need to recoup any product development costs, potentially a major factor in its low price. From the perspective of the Indian public, the device may have fulfilled its purpose by crashing prices for most artificial heart valves. The fact that the Chitra valve continues to gain ground in India and around the world is a testament to its quality and adaptability.


Could the TTK Chitra Heart Valve Succeed in the U.S.?

The structural challenges facing the TTK Chitra Heart Valve in the U.S. are considerable. First, as a Class III medical device, price becomes less important relative to quality, and the bileaflet artificial valve models--though much more expensive--have marginally better performance in many use cases. Only serious cardiovascular surgery centers perform heart valve replacements, and these will likely opt for products that exhibit even marginal medical benefit over others, at least to protect themselves from unnecessary legal liabilities.

Second, there are homegrown disruptive medtech innovations for certain operations in this space. For example, the MitraClip is a device approved by the US FDA as a less invasive way to treat mitral regurgitation due to degenerative disease in patients with prohibitive risk for mitral valve surgery. This targets a substantial portion of the market for valve replacement as mitral valve regurgitation is the most common form of heart valve disease in the U.S., suggesting that there are even more Mitral Valve Replacement surgeries per year than the 20,000 or so Aortic Valve Replacement surgeries per year.

Third, biological valve replacements are often preferred for placement is elderly patients, who form the bulk of patients requiring heart valve replacement surgeries in the U.S.. While biological valves are not as durable as artificial valves like Chitra, they don't require additional blood-thinning medicines, and are associated with a lower risk for blood clots.

While the TTK Chitra Heart Valve's low price could be a major boon to certain U.S. patients shopping for low-cost heart valve replacement surgeries, these patients may need to content themselves with medical tourism for the time being. One good option may be Narayana Health's hospital in the Cayman Islands, which specifically targets medical tourists from the Americas.


Question for Discussion: 
  • Is there demand for a low-cost heart valve like the TTK Chitra Heart Valve in the U.S.?  

5 comments:

  1. Couple of clarifications received from TTK Healthcare: They are not yet approved by the US FDA, but have been approved by competent Indian agencies. The manufacturing facility has been certified in accordance with ISO 9001:2000/ EN ISO 9001:2000/ JIS Q 9001:2000 by RW TUV systems GmbH.

    They are in process of receiving CE Mark approval for the device, and estimate receipt in 2-3 months. This report gives an excellent overview of many successful clinical trials the device has participated in: http://www.slideshare.net/pranavshamraj/ttk-chitra-valve-a-review

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