Absorb (the bioresolving stent)

Absorb is the bioresolving stent being the nonmetallic mesh tubule made of a polylactide — the same material from which the self-resolving surgical threads are produced. Absorb is intended for treatment of a disease of coronary arteries using expansion of the narrowed vessels and recovery of a blood-groove to heart. After a while the artery purchases capability again to be left expanded without support, then the Absorb stent begins to resolve gradually up to complete disintegration on molecules of water and carbon dioxide.

2017

Turning of sales

In September, 2017 Abbott Laboratories announced the termination of sales  of the soluble Absorb GT1 stent. Though the company connects the solution with the flat demand on the device, problems with health which are caused by it to patients can be the real cause.

According to the statement of Abbott, the vascular Absorb GT1 frame system on September 14, 2017 bioresolving is removed from sale because of the flat demand, more precisely because of "lack of commercial rationality".

Absorb GT1 stent

Absorb is the device of the first generation which demanded more time at implantation, than metal stents. The sales volume of Absorb was low. Expenses on production Absorb were higher, than sales that made it an irrational product. We continue to work on the bioresolving technology of the second generation which has a smaller profile and the improved performance that allowed to reduce implantation time — the representative of Abbott Jonathon Hamilton said to the StarTribune edition.

According to him, less than 1% of sales of stents of the company on a global scale were the share of Absorb.

Use of soluble stents prevents such long-term ghost effects as insufficient flexibility of a vessel, a possibility of its damage or acceleration of atherosclerotic process  in the field of the device.

Absorb GT1 is contraindicated to patients with  hypersensibility to  any of  components of the stent or contrast substance, necessary for installation,  and also with  contraindications for long administration of drugs, interfering a trombobrazovaniye.

In March, 2017 the Food and Drug Administration (FDA) announced conducting investigation in connection with numerous complaints to work of heart from patients to whom implanted Absorb. Then it was noted that the amount of ghost effects from use of this resolving stent is higher, than at traditional metal products of the same producer.^[1]

Limited use in Europe

In April, 2017 the Abbott Laboratories company announced that the bioresolving Absorb stents will not extend everywhere in the European market. This statement was made after a series of complaints to these products.

According to the message of Abbott distributed among medical institutions, vascular Absorb stents will be available only in some hospitals and clinics. Restrictions will become effective on May 31, 2017. In the summer the producer intends to review a situation as a result of close interaction with the European regulators.

The bioresolving Absorb stent

Post-marketing registers begin to be implemented in Europe for control of the technology of implantation of the self-resolving Absorb stents. These European registers in parallel have pilot studies and training in other parts of the world. For example, Absorb IV are investigated on the example of 3 thousand patients in the USA — noted in Abbott.

In the fall of 2016 results of a three-year research according to which at users of the bioresolving Absorb II stents the high level of development of a myocardial infarction was revealed were published. The same was shown by clinical trials of the Absorb III model.

In March, 2017 the AIDA organization stopped clinical testing of Abbott stents at an early stage after detection of high extent of development of thrombosis of the stent.^[2]

Notes