Abbott announced on 11 June that it has initiated the ABSORB Japan randomised controlled clinical trial to evaluate the Absorb bioresorbable vascular scaffold in patients with coronary artery disease. The results of this trial are intended to support regulatory filings with the Japanese Pharmaceutical and Medical Devices Agency (PMDA) for approval of Absorb in Japan.
The Absorb, a drug-eluting, fully bioresorbable vascular scaffold, is a small mesh tube designed to open a blocked heart vessel, restore blood flow to the heart and then dissolve into the vessel over time, according to a company release. Absorb is made of polylactide, a naturally dissolvable material that is commonly used in medical implants such as dissolving sutures.
ABSORB Japan is expected to enrol approximately 400 patients and compare the performance of Absorb to Abbott’s Xience family of metallic drug-eluting stents. The primary endpoint is target lesion failure at one year, a combined measure of safety and efficacy of the device. Takeshi Kimura, Department of Cardiovascular Medicine, Kyoto University Hospital, Japan, is the principal investigator of the ABSORB Japan trial.
“Unlike permanent metallic stents, Absorb dissolves over time, which may allow the blood vessel to regain natural function, a unique effect that could have significant impact on the way coronary artery disease is treated in Japan,” said Kimura. “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.”
The trial also will incorporate state-of-the-art imaging techniques to study the impact of treatment with Absorb in the blood vessel. The first patient in ABSORB Japan was enrolled by Shigeru Saito, director, Cardiology and Catheterization Laboratories, and vice president, Shonan Kamakura General Hospital, Kanagawa, Japan, who also enrolled the first patient in the ABSORB EXTEND trial in Japan— a prospective, single-arm trial initiated by Abbott in January 2010 in Japan and other international markets (including Europe).
According to the release, data from the ABSORB EXTEND trial and other international trials have been presented at major medical meetings and continue to support the near-term safety and efficacy of Absorb across traditional measures typically used to evaluate a drug-eluting stent. Ongoing evaluation will continue in randomised trials, such as ABSORB Japan, to understand the long-term benefits of a device that dissolves completely over time.
“The deliverability of this device during a procedure is similar to a best-in-class drug eluting stent, which is important for treating blockages with ease and confidence in a range of patients,” said Saito. “We anticipate continued, growing enthusiasm about Absorb from physicians and patients. By leaving no permanent implant behind, this innovative device has the potential to provide benefits never before seen with metallic stents.”
Abbott also reported that it recently completed enrolment for ABSORB II, a randomided trial initiated in Europe and New Zealand in November 2011.
Absorb is an investigational device, limited by USA law to investigational use and is not approved or available for sale in the USA. Absorb is authorised for sale in CE mark countries. Absorb is available in Europe, the Middle East, parts of Latin America, and parts of Asia Pacific, including India, Hong Kong, Malaysia and New Zealand.