A tumultuous year for Abbott's bio-absorbable stent `Absorb' comes to an end with the United States-based healthcare major pulling the plug on its dissolvable cardiac product.
The final blow was delivered on the niche product because of low commercial sales, globally. “Due to low commercial uptake, Abbott will stop selling the first-generation bioresorbable Absorb coronary stent,” a company spokesperson said. The volume of Absorb sold was low, “ it cost more to make Absorb than what we could sell it for – making it unsustainable,” the spokesperson said explaining why it was discontinued.
The irony is that the latest decision comes a little over a year after Abbott had received US regulatory approval to sell Absorb on home-turf. In fact, Absorb's US approval had come about four years after the product had been approved in India. And there in lies the concern.
For the 18,000 odd patients who have an Absorb stent in them, Abbott will have to not just allay their fears on the product but also commit future support when the present controversy has passed.
Abbott has got in touch with local regulators and will continue monitoring long-term outcomes in on-going Absorb trials, the spokesperson said. “We continue to align with Indian regulatory norms related to the follow-up of implanted individuals,” the company said. Doctors dealing with Absorb are also being contacted to update them on the discontinuation.
Absorb accounts for less than 1 percent of Abbott's overall stent sales globally, including in India.
No residues
A stent is a wire-like mesh inserted into blood vessels to remove blockages and it is used largely to remove heart blocks. But Absorb had caught the fancy of many because it did not leave a residual metal in the body like other cardiac stents.
Once the product is absorbed, there are only four very small platinum markers embedded in the walls of the artery, which help cardiologists identify where Absorb was originally placed, the US Food and Drug Administration had said, when it approved the product last year.
Though the product may have benefited complicated heart conditions in young people or those needing multiple stents, the US regulator and cardiologists had cautioned that the product was prone to more blood clots than a regular drug-coated stent.
Pricing storm
Absorb was also at the heart of the pricing storm in India, when the National Pharmaceutical Pricing Authority (NPPA) slashed margins and capped prices on cardiac stents this year, its first such move on medical devices.
Absorb priced at close to Rs 2 lakh for the innovation it apparently brought to the table was clubbed in the same category as other drug-eluting stents whose prices were capped at Rs 30,000.
Abbott then approached the NPPA in April to pull out Absorb and another stent, Alpine, from the Indian market.
However, that was not the end of Absorb's troubles as it had to weather more storms in Europe and Australia subsequently, where its deployment was restricted following safety concerns on the cardiac product.
“Absorb is a first-generation device that took longer to implant to get the best results. First-generation products often go through iterations as experience is gained using them. Absorb is a highly innovative ground breaking device, and we're incorporating learnings into a second-generation product,” the company said.
Meanwhile, Abbott's XIENCE drug-eluting stent will be the cornerstone of its portfolio globally and in India. The focus will also be on a next-gen metallic drug-eluting product XIENCE Sierra that offers improved deliverability and expanded sizes, in addition to imaging and physiology assessment tools that help doctors perform complex interventional procedures, the company said.
Explaining its rationale behind researching bioresorbable technology, Abbott said that they believed patients could live “without permanent metallic implants”. The second-generation device Abbott is working on “has a thinner profile and is easier to deliver,”they said.
For the moment though patients with Absorb implanted in them may well be advised to speak to their doctor to clear any concern on the discontinued product.