It is fair to say that bioresorbable drug-eluting scaffolds have failed to live up to their promise. The first and best known of these, Abbott’s Absorb, was pulled from sale in 2017 after failing to sell. Now another group making these products, Reva Medical, has filed for bankruptcy protection.
Reva’s device, called Fantom, gained EU-wide approval three years ago. Six months later Absorb was withdrawn, and dissolving scaffolds, always regarded with a certain amount of suspicion by interventional cardiologists, were suddenly yesterday’s news. Some companies are still contesting the market, but sales of these technologies are far below those of the drug-eluting stents that inspired their development.
Drug-coated vascular scaffolds made of materials that are naturally broken down within the body were developed as an alternative to metallic stents, providing mechanical support to narrowed blood vessels and delivering anti-regrowth drugs for only as long as necessary. Metal stents are permanent implants, and after all their drug coating has leached away they remain in place, preventing the blood vessel from flexing in the same way as an untreated one.
In the early 2010s it was felt that they might outsell metal stents. Five years ago, the sellside forecast 2020 sales of $825m for Absorb (Absorb data could allow Abbott to retain stent leadership, October 13, 2015).
But data showing high rates of late-term adverse events including heart attack and thrombosis at two years caused such a hit to sales that it never recovered, and eventually the device was pulled.
Other companies, including Reva and Amaranth Medical, said at the time that this was due to strut thickness: Absorb was too chunky and inflexible. They argued that scaffolds with thinner struts were safer and easier to use.
This argument seems to have come to nothing with Reva’s bankruptcy. The company stated that clinical data on Fantom and the next-generation Fantom Encore device were “excellent”, but conceded that adoption of dissolving scaffolds “has been greatly impacted by concerns with clinical data from inferior competitive devices”.
Amaranth, whose Magnitude and Aptitude scaffolds never actually gained CE mark, also appears to be inactive.
|Status of selected bioresorbable scaffolds|
|Abbott||Absorb||Polylactic acid||Everolimus||CE marked Jan 2011; FDA approved Jul 2016; withdrawn from sale worldwide Sep 2017|
|Reva Medical||Fantom||Desaminotyrosine polycarbonate||Sirolimus||CE marked Apr 2017; company filed for bankruptcy protection Jan 2020|
|Amaranth Medical||Aptitude||Polylactic acid||Sirolimus||CE mark had been expected Dec 2017; company website now defunct|
|Amaranth Medical||Magnitude||Polylactic acid||Sirolimus||CE mark had been expected in Mar 2018; company website now defunct|
|Elixir Medical||DESolve||Polylactic acid||Novolimus & myolimus||CE marked May 2013|
|Arterial Remodeling Technologies||Pure||Polylactic acid||No drug||CE marked May 2015|
|Biotronik||Magmaris||Magnesium alloy||Paclitaxel||CE marked Jun 2016|
|Meril Life Science||MeRes 100||Polylactic acid||Sirolimus||CE marked Aug 2019|
|Source: EvaluateMedTech & company websites.|
This leaves a handful of companies still selling dissolving scaffolds. Elixir Medical was the second to market with its DESolve device, and this appears still to be on the market, but the company is private and does not disclose sales. The same goes for Biotronik and Arterial Remodeling Technologies, whose devices are unique among the marketed products in different ways: Biotronik’s is made of a bioresorbable metal alloy, and Arterial Remodeling’s scaffold is not coated with an antiproliferative drug.
The most recent entrant is the Indian group Meril Life Sciences, whose MeRes 100 device was launched last summer, and has “a small presence” in Europe and India, according to Sanjeev Bhatt, the group’s vice-president of corporate strategy.
“The scientific community is still not decided about how they wish to pursue bioresorbable scaffolds,” he told Vantage in November, “but we’ve indulged very seriously in developing, establishing the clinical safety and efficacy of a thin-strut bioresorbable scaffold. We continue to have an interest in that area.”
The chances of the scientific community suddenly opting to use these products in large numbers seem pretty low.