Closing the Absorb chapter

October 17, 2017 – 2:37 PM | By Omar Ford | No comments yet

Two years ago, my youngest child was just learning how to walk and analysts were praising Abbott Laboratories’ bioresorbable vascular scaffold.

Flash forward today – my son is riding his bike like a true champ (with training wheels) and Abbott is  singing a different tune about bioresorbable stents. absorb-dissolving-stentIn fact, the Abbott Park Ill.-based company isn’t singing any tunes about Absorb at all.

Oh, what a difference two years can make.

Earlier this month, Abbott announced that it was discontinuing sales of its Absorb stent – citing low sales as the reason. The news broke on a quiet Friday afternoon – with nothing more than  simple statement from the med-tech heavyweight.

The news was big.  But was it unexpected? Did anyone see this coming? Was it out of the blue?

I mean there was so much potential Absorb. 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.

If you go back to March and look at any med-tech article discussing Absorb, then you can plainly see the writing was on the wall for the device to be pulled from the shelves.

I mean in March, Abbott revealed that it was restricting the use of Absorb in Europe to clinical registries;  the FDA issued a Medwatch alert suggesting Abbott’s Absorb carried too high a rate of major adverse cardiac events and  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 under-performed, failing to deliver better long-term outcomes and reinforcing concerns of increased stent thrombosis, including late stent thrombosis.

Again all of that happened in March. Ouch.

bandaid

Now if you paid close attention to Abbott’s rival, Boston Scientific, you could probably see the writing on the wall. I can remember speaking with execs from the Marlborough, Mass.-based company two years ago about the prospect of a fully  Absorbable stent.  I even mentioned Abbott’s Absorb. Even back then Boston Scientific was skittish on a commitment to an absorbable stent program. Instead Boston Scientific wanted to 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.

Now Boston Scientific would go on to start its own absorbable stent program.  But after Abbott’s March madness with Absorb (I can call it March Madness right?),  the Marlborough, Mass.-based company put a halt to the dissolving stent idea real quick. In July, Boston Scientific proclaimed that it was abandoning bioresorbable stents. Boston Scientific even allowed a distribution agreement with Reva Medical Inc., another bioresorbable stent maker, to expire. (See BioWorld MedTech, Aug. 7, 2017.)

In August, Timette Nevala, manager of communications for Boston Scientific’s Interventional Cardiology & Peripheral Interventions, told BioWorld MedTech that “first-generation bioresorbable stents have demonstrated poor acute performance and increased safety concerns, limiting their use in real-world clinical settings.”

So what happens next. Well hopefully my son will drop his training wheels soon, and  as for Abbott, well the company said it will still continue to work on its second generation bioresorbable stent and learn from continue to follow implanted patients in existing Absorb clinical trials to assess long-term outcomes after the scaffold has dissolved.

But as for the first generation stent – well that chapter is closed.

 

 

 

 

 

 

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