Diversified medical firm Abbott Labs (ABT -0.65%) has begun a new clinical trial of its Absorb bioresorbable next-generation stent that will judge its safety and efficacy in patients with coronary artery disease, or CAD.
The randomized study will be used to support approval of the Absorb stent by Japanese regulators, according to Abbott. The ABSORB Japan trial will enroll approximately 400 patients. The primary endpoint is "target lesion failure (TLF) at one year, a combined measure of safety and efficacy of the device." Absorb stents dissolves over time and that may allow the blood vessel to regain natural function, said the company.
According to Abbott, CAD is the leading cause of death in the world and the World Health Organization estimates that the disease causes one-third of all deaths in Japan. Abbott launched a similar trial of the Absorb stent in the U.S. in January.
The company has plenty of prior experience with drug-eluting stents. Its Xience family of stents is a leader in the current market and sold nearly $1.6 billion last year, a 3% year-over-year gain. The Absorb improves upon the Xience by offering a "scaffold" that dissolves completely in the blood stream over time.
