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Company halts sales of controversial product

By Omar Ford

Staff Writer

Abbott Laboratories Inc. said it will stop selling its Absorb bioresorbable vascular scaffold (BVS), citing low commercial sales as the reason for the decision. The Abbott Park, Ill.-based company first received FDA approval for Absorb in July of last year. (See BioWorld MedTech, July 6, 2016.) But a series of setbacks and safety concerns significantly hindered adoption of the technology.

The company said sales of the device would be discontinued worldwide by Sept. 14.

"We pioneered bioresorbable technology because we believe it offers patients the possibility of life without permanent metallic implants, and we will continue work on a next-generation bioresorbable device," Kristina Becker, a spokesperson for Abbott, told BioWorld MedTech. "We'll also continue to follow implanted patients in existing Absorb clinical trials to assess long-term outcomes after the scaffold has dissolved."

Abbott's promise of having an bioresorbable stent was all the rage a few years ago.

Unlike traditional, permanent metallic stents, Absorb was designed to be completely absorbed by the body in three years, leaving behind only two small metallic markers in the diseased coronary artery. Abbott has said the lack of a permanent structure in the artery allows what's known as "a return to vasomotion," meaning the artery returns to its natural state and is not dependent on a foreign material for structure support. Metallic stents can also physically impede future interventions.

Approval of the device was based on the 2,000-plus ABSORB III randomized clinical trial, which found the technology to be noninferior to the company's Xience drug-eluting stent (DES).

However, Absorb's potential promise came crashing down.

In March, Abbott revealed that it was restricting the use of Absorb in Europe to clinical registries that were being started in order to collect additional real-world data. That same month FDA issued a Medwatch alert suggesting Abbott's Absorb carried too high a rate of major adverse cardiac events (MACE), at 11 percent, in its two-year ABSORB III study. The rate, which marks endpoint of heart attack, cardiac death or revascularization, was significantly higher when compared to Abbott's Xience DES (7.9 percent MACE). At the same time, the thrombus rate also was higher at 1.9 percent compared to 0.8 for Xience.

Things continued to go downhill for Abbott in March, when the 1,850-patient, Amsterdam Investigator-initiateD Absorb Strategy All-comers Trial (AIDA) was terminated early by the data and safety monitoring board. Results from AIDA showed that Abbott's stent underperformed, failing to deliver better long-term outcomes and reinforcing concerns of increased stent thrombosis, including late stent thrombosis.

In April, Larry Biegelsen, an analyst with Wells Fargo, wrote, "Based on these events, we already expected the commercial use of Absorb to significantly decline. Given the recent issues with Absorb, ABT may decide to pursue another novel technology such as a DES with a bioabsorbable polymer."

Raffaele Piccolo, of the department of cardiology at Bern University Hospital in Switzerland, wrote in an editorial in the July 18, 2017, edition of The Lancet that there is "evidence beyond any reasonable doubt that Absorb BVS is inferior to new-generation [metallic everolimus-eluting stents] on both efficacy and safety throughout two years."

Doubts mounting in industry

Absorb's string of bad news sent ripple effects throughout the industry, causing Abbott's rival, Boston Scientific Corp., to abandon its bioresorbable stent program back in July. The Marlborough, Mass.-based company even allowed a distribution agreement with Reva Medical Inc., another bioresorbable stent maker, to expire. (See BioWorld MedTech, Aug. 7, 2017.)

"First-generation bioresorbable stents have demonstrated poor acute performance and increased safety concerns, limiting their use in real-world clinical settings and ultimately resulting in a market that is developing more slowly than previously expected," Timette Nevala, manager of communications for Boston Scientific's Interventional Cardiology & Peripheral Interventions, told BioWorld MedTech in August. "Additionally, long-term clinical data has demonstrated higher safety risks with bioresorbable stents, as seen with the regulatory actions taken against Abbott's Absorb, which have included a recent FDA warning to U.S. physicians as well as severe use limitations in Europe, Japan, Australia and other countries. As a result of these outcomes, we made the decision to not pursue distribution of first-generation bioresorbable stents."

Boston Scientific had been initially reluctant about embracing the idea of bioresorbable stents.

During a 2015 interview with BioWorld MedTech, Boston Scientific said, "The international usage and penetration rates of fully bioresorbable stents are somewhat disappointing." (See BioWorld MedTech, Oct. 6, 2015.)

The company went on to say that future generations of fully bioresorbable stents might have a place in the clinic, but more data were needed before the stents might have a workhorse type of appeal.

Boston Scientific suggested it will, instead, focus on its Synergy technology, a partially resorbable stent that was awarded FDA approval in October 2015. The device's coating is designed to dissolve after the associated drug is dispensed, while the metallic stent remains in place. (See BioWorld MedTech, July 6, 2016.)

To date, Absorb's competitors are Berlin-based Biotronik AG's Magmaris stent, and Sunnyvale, Calif.-based Elixir Medical's Desolve, which have CE mark approval.

Published  September 11, 2017

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