24 December 2015 07:55:30 IST

A tale of 2 facilities, 2 cardiac devices

Abbott’s Absorb stent and MitraClip expect to see regulatory progress in 2016

As rows of people sit bent over tables dressed in protective white suits, glasses and even beard-covers, it’s business as usual at Abbott’s Menlo Park research and production facility in the San Francisco Bay Area.

They are making the intricate MitraClip used to treat a debilitating, progressive and life-threatening heart ailment (mitral regurgitation), where a leaky mitral valve causes a backward flow of blood in the heart. Left untreated, the condition raises the risk of irregular heartbeats, stroke and heart failure.

About a seven-hour drive away at another Abbott site in Temecula, the scene is not very different. Entry here requires further reinforced protective gear including two sets of hand-gloves and a double shoe protection.

This facility makes drug eluting stents and Absorb, Abbott’s breakthrough bio-absorbable stent. (A wire-like mesh, stents are inserted into blood vessels to remove blockages, largely used in heart procedures). Unlike a regular metal or drug-coated stent, with Absorb, there is no metal left behind in the body in three years. But the silent activity at both facilities belies the excitement expected around Absorb and MitraClip in 2016, in the US and India.

Green signal Absorb may finally become available in the US, once it gets the green signal from the Food and Drug Administration, expected in late 2016. And MitraClip expects to see more preparatory regulatory work in India next year.

Abbott has been partnering with the Indian regulatory authority on MitraClip since 2010 and is “currently in active negotiations with the agency in the regulatory approval process for the novel MitraClip technology,” said Joanna Develter, Abbott’s Vascular Regulatory Affairs Director.

A positive development on either product will impact the Menlo Park or Temecula facilities that supply these critical heart devices, globally.

Keeping a close watch on these regulatory developments will be health workers in India, as healthcare and, indeed, medical devices, come in for close scrutiny from a pricing viewpoint.

The development of an implantable device is rigorous and requires a different engineering to be in the body, said Jamey Jacobs, Divisional Vice-President, R&D, Abbott’s vascular business.

Scientists and engineers work together to combine design with the right material, so the device can do the right thing for a long period of time in the human body with least risk, he said.

A scientist-engineer and Director R&D (Abbott’s Structural Heart portfolio), Santosh Prabhu explains that critical implants do a balancing act between performance abilities, combining strength and flexibility.

The MitraClip, for instance, consists of 22 parts deftly put together by machine-assisted manual operations.

Contradictory to popular perception that high-end implants are totally machine cut and mechanical, employees at these facilities demonstrate how almost every operation has a manual and machine element.

“Skilled manual work is a crucial component of the manufacturing process and the amount and capability of the workforce to build the product is significant,” said Mike Webber, operations in-charge at Temecula. Machine operations require stringent levels of manual oversight to ensure high level of quality, he added.

Explaining how Abbott walks the fine line between innovation and price, Jacobs said: “We start with the goal that our products and therapies improve outcomes and reduce healthcare costs.

“Ultimately the best products should have good long-term outcomes, which reduce the need for future procedures, interventions or visits to the doctor. When we create products like this, the by-product is a reduction of costs to the healthcare system through better patient outcomes.”

Absorb already sells in India and is priced at less than ₹2 lakh. About 17,000 Absorbs are estimated to have been used in India.

India landscape On MitraClip’s significance, officials expect India to show a similar disease profile as the US where mitral regurgitation affects nearly one in 10 people aged 75 or more.

But numbers aside, MitraClip helps treat people who cannot undertake surgery (especially the elderly), improving the quality of life in a disease that makes daily activities difficult.

And the coming year will be significant for patient access to MitraClip and Absorb, in India and the US, respectively.

(The writer was in the US at the invitation of Abbott)