New Delhi: Abbott Laboratories, one of the biggest makers of coronary stents, announced halting global sales of their fully absorbable stent-Absorb Bioresorbable Vascular Scaffold (BVS) citing low “commercial sales".
Once hailed as the next big breakthrough in medical devices, the first-generation Absorb BVS, the first and only fully dissolving heart stent was approved by the US Food and Drug Administration (FDA) in July 2016 to treat patients with coronary artery disease.
In a statement posted on Friday on its website, the company said it is discontinuing all sizes of the Absorb bioresorbable vascular scaffold system, effective 14 September. The halt includes both the Absorb and Absorb Gt1 Bioresorbable Vascular Scaffold Systems.
In India, Abbott had earlier too filed an application with the National Pharmaceutical Pricing Authority(NPPA) to withdraw its premium stents from the market stating commercial “unsustainability" after the Indian government had capped the prices of coronary stents at Rs29,600.
According to Abbott spokesperson, Absorb sales accounted for less than 1% of Abbott’s overall stent sales globally, including in India. “We are in touch with regulators and the pricing authority in India and have informed them on the discontinuation of Absorb globally due to low commercial sales".
The revolutionary dis-solvable stent, Absorb, were priced at Rs1.9 lakh each before the cap. While the price regulator squashed the request of Abbott to withdraw the latest generation of stents, the bioresorbable stents came under the scanner after red flags were raised on safety of the device by drug regulators in the US, Europe and Australia following the results of two big research trials that showed an elevated rate of major adverse cardiac events, specifically heart attack and blood clot, when compared to patients treated with a metallic stent.
India’s drug regulator issued an advisory asking patients and medical professionals to report any adverse events, an expert panel was also formed by drug controller to study these stents. The panel warned against the use of stents that are 2.5mm or narrower. For larger vessels, the regulator has said that the bioresorbable stents may be used, but only in controlled settings.
Even as the company clarified “safety" being not the reason for the withdrawal, cardiologists beg to differ.
“On 8 September Abbott stopped the sales of Absorb BVS in more than 100 countries including India, the exact reason according to cardiology community is the poor results shown in various large trials (AbSORB III) which showed increased rate of complications by this device. But it should not be considered as end of next generation technology. There is an immense potential in this technology. The poor results of this first generation device were because of increased strut thickness of his stent, poor implantation technique and poor patient selection. If proper techniques are utilised and the strut thickness is reduced then this technology has immense potential for heart patients," said Dr Nishith Chandra, Director Intervention cardiology, Fortis Escorts Heart Institute.
Abbott said that physicians with existing products are free to implant the devices “if they choose to do so". Additionally, the company “will continue to follow patients in existing clinical studies per protocols." “ 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. We’ll also continue to follow implanted patients in existing Absorb clinical trials to assess long-term outcomes after the scaffold has dissolved. We’re dedicated to developing treatments that help patients with vascular and other heart diseases live their fullest lives," Abbott wrote.
Ganesh Sabat,CEO, Sahajanand Medical Technologies Pvt.Ltd (SMT) said, “Medical device industry has seen tremendous progress over last two decades. The withdrawal of the BVS stent teaches us that there has to be a meaningful progress for the Interventional cardiologist and customers to embrace with conviction. Interventional cardiology industry will take this into its stride and will continue to do cutting edge research and will come back with more efficient and safe products."
Meanwhile, Abbott said that their metallic XIENCE drug-eluting stent will continue “to be the cornerstone of our portfolio globally and in India, and we will focus efforts on a next generation metallic drug-eluting product, XIENCE Sierra, that offers improved deliverability and expanded sizes; and to imaging and physiology assessment tools that help doctors perform complex interventional procedures".