U.S. to vie with India for top bioabsorbable stent market after FDA approval

Bioabsorbable stents are projected to account for 17% of global procedure volume by 2021, up from less than 2% in 2014, said GlobalData analyst Amen Sanghera during a recent webinar. He's a bull on the emerging technology, and estimates a compounded annual growth rate of 56.7% over that time period.

Bioabsorbable stents (also called bioresorbable stents) are absorbed by the body 12 to 24 months after implantation, resulting in a bevy of benefits over their drug-eluting and bare metal cousins, including a reduction in restenosis (renarrowing of the vessel following stenting), the restoration of normal vessel function following the stent's degradation, and a reduction in the need for long-term antiplatelet therapy. In addition, permanent stents can be a barrier to invasive surgeries.

Abbott's ($ABT) Absorb BVS will remain the market leader by a wide margin, Sanghera said. FDA approval is expected in 2016. The Absorb is projected to hit sales of $96.3 million by 2017 in the U.S. once commercialization commences.

But India is its largest market right now, accounting for slightly more than a third of its $132 million in 2014 global revenues, followed by Brazil, which is responsible for more than a fifth of the total. France, Germany, Italy, Spain and the U.K. account for the rest.

The device fits the bill of one that the FDA has been slow to approve compared to its global counterparts. Abbott is also aiming to launch the Absorb in Japan and China, Sanghera said.

In fact, there are two other bioabsorbable stents on the market in Europe, though neither has made much of a dent in the market: Elixir Medical's DESolve and this year's new entrant, Pure, from Arterial Remodeling Technologies.

All are composed of bioabsorbable polymers. The main difference is the drug that they elute, or don't elute in the case of Pure. DESolve has a slightly thinner strut thickness than the Absorb (150 micrometers vs. 156 micrometers), which gives it a theoretical advantage.

Sanghera said Pure lacks clinical data, and predicted little clinical uptake. The fact that it does not elute any medications could also be a disadvantage. The analyst was also bearish on Biotronik's clinical-stage metallic bioabsorbable stent, Dreams, saying magnesium has been associated with unwanted inflammation.

Bioabsorbable stents can be improved by developing scaffolds that are thinner, stronger and more flexibility, Sanghera said. Faster absorption times, more efficient drug elution, and better delivery systems would also help, as would making scaffolds that are visible under different imaging modalities.

Government (and in the case of the U.S., private) reimbursement will be critical to securing adoption of the third generation of stents, which represent the next treatment paradigm following bare metal and permanent drug eluting versions.

GlobalData isn't as excited about bioabsorbable stents for peripheral conditions. Sanghera said they aren't as effectively clinically in peripheral arteries. Kyoto Medical's Remedy peripheral stent hasn't had much success despite receiving a CE mark in 2007. Abbott aims to enter the European market with its Espirit peripheral bioabsorbable peripheral stent in 2016.

-- Varun Saxena (email | Twitter)