Abbott Laboratories ($ABT) said a "positive" one-year clinical result in Japan comparing its dissolvable Absorb heart stent to Xience represents a milestone for the product, currently an investigational device in the country as well as the U.S. and not approved for commercial use.
For Abbott in Asia, the trial potentially extends its device reach in the region's top reimbursement market as it works with Johnson & Johnson ($JNJ), GE Healthcare ($GE) and Boston Scientific ($BSX) in the Asia Pacific Medical Technology Association, or APACMed, launched in April to focus on regional regulatory and commercial industry issues.
On the second-quarter earnings call, Abbott executives gave some hints of the schedule for approval submission in Asia but stayed largely mum on the trial.
"During the quarter we completed regulatory submissions for approval of Absorb in both the U.S. and Japan and expect to submit in China in the coming months," said Scott Leinenweber, vice president of investor relations, on the July 22 earnings call.
"Collectively these markets represent more than 50% of the world's coronary stent market. We also enhanced our Absorb product offering in Europe with the approval of Absorb GT1, a new advancement of the Absorb stent system that improves ease-of-use."
When pressed by an analyst for details, Brian Yoor, senior vice president of finance and chief financial officer, said "at this point we don't have any further information to report on the details of the trial."Abbott CEO Miles White
Miles White, chairman and CEO, chimed in to say "as long as you asked about Absorb, I was pleased to see that the vascular business sequentially here while it's not booming double digits is still improving quarter to quarter. And even though these are low single-digit numbers for Vascular that's an improvement over what we've seen say the last year and a half, 18 months or whatever. So I'm pretty happy about that."
Though the release offered no clarity on approval timelines, the company said the results will be featured at a late-breaking session today at the European Society of Cardiology Congress 2015, before going on to outline the unique properties of the device.
"The Absorb Japan results contribute to the growing body of Absorb data, providing further clinical evidence that the fully dissolving stent initially functions like a permanent, metallic stent by opening up blocked heart vessels and restoring blood flow," said Dr. Charles Simonton, chief medical officer and divisional vice president of medical affairs, vascular, in a release. "However, unlike a metallic drug eluting stent, Absorb naturally dissolves over time, leaving nothing behind. The fact that Absorb completely dissolves means that the restored vessel has the potential to move as it needs to, based on lifestyle activities."
Last year, Abbott announced broadly positive results from its European Absorb II trial, though some differences emerged in the latest data with doctors cautious because they were unfamiliar with the device's properties. The mean balloon pressure used was 14.23 atmospheres, compared to 15.03 atmospheres when implanting the Xience, for example.
- here's the release