|Abbott is looking to get Absorb on the Japanese market with a new study.--Courtesy of Abbott Laboratories.|
Abbott Laboratories ($ABT) has met success at every turn with Absorb, the company's dissolvable stent, and now it's kicking off a trial to get the device on the market in Japan.
In a study of about 400 patients, Abbott will compare Absorb's safety and effectiveness to its line of Xience stents, submitting the results to Japan's Pharmaceutical and Medical Devices Agency for approval. Absorb is already available in CE mark countries across Europe and Asia, indicated to treat coronary artery disease.
Abbott has thus far reported nothing but positive results in its 5 previous studies of Absorb, and the early commercial response to the device has been positive, the company said. In India alone, doctors have implanted more than 2,500 Absorb stents since the device's launch in late September.
Abbott is hoping to duplicate that success in Japan, where cardiovascular disease accounts for one-third of all deaths, principal investigator Takeshi Kimura said.
"While the clinical outcomes of Absorb have been demonstrated in international clinical trials, we now have the opportunity to understand the impact of this technology in Japanese patients in a comparative study, and hope the results of this effort support the process to make Absorb widely available for clinical use in Japan in the future," Kimura said in a statement.
The global excitement over Absorb is just what Abbott needs to reverse the fortunes of its ailing vascular segment. Since cleaving its proprietary drug business into AbbVie ($ABBV) this year, Abbott has struggled with declining demand for its legacy stents, and, last quarter, vascular sales dropped 7.7% total and 19.3% in the U.S. alone.
But CEO Miles White has said the company expects Absorb to become "a workhorse stent for us over time," and Abbott was the first company to commercialize a dissolvable stent. On its heels are Boston Scientific ($BSX), Elixir Medical and others, but Abbott will likely score the same first-mover benefit in the U.S., as the company is in the midst of an FDA-targeted trial of 2,250 patients.
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