This article is a collaboration between MedPage Today® and:
Boston Scientific said its Synergy bioabsorbable polymer drug-eluting stent is the first such device to receive marketing approval from the FDA.
In a statement, the company said the FDA approval was based on results from the EVOLVE II trial, which were reported in November 2014 at the American Heart Association meeting.
The study assigned 838 patients to receive the PROMUS Element Plus drug-eluting stent and 846 patients to receive the Synergy stent. More than two-thirds of the patients were men and the average age was 63.
In a per protocol analysis, EVOLVE II demonstrated noninferiority (P =0.003) with 6.4% of the Synergy patients and 6.4% of controls experiencing the target vessel failure at 12 months.
"Boston Scientific will continue to advance the robust clinical program supporting the SYNERGY Stent with the initiation of the EVOLVE Short Dual Anti-Platelet Therapy (DAPT) Study, expected during the first quarter of 2016. The company has received an Investigational Device Exemption (IDE) for this prospective study designed to assess the safety of 3-month use of DAPT in patients at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent," the company said in its press release.
The stent "features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at 3 months, thereby eliminating long-term polymer exposure."
Synergy was approved for use in Europe in 2012.
While Synergy features a bioabsorbable polymer, the "holy grail" in the stent world is a fully bioabsorbable platform. Last month, that bioabsorbable technology was featured at the European Society of Cardiology, with latest findings from Abbott Vascular Technology's Absorb stent. At that time, ABSORB investigator Patrick W. Serruys, MD, PhD, told MedPage Today that progress with resorbable technology has been slow, but steady.
The text is a press release and article summary about the FDA approval of Boston Scientific's Synergy bioabsorbable polymer drug-eluting stent, including details about the clinical trial that led to its approval and future studies planned for the device.
no_question
Given a text passage, determine:
    1. If it contains a mathematical question (including word problems or calculations)
    2. If an answer to that mathematical question is provided in the text

First, describe the content structure you found in 1-2 sentences.

Then provide your analysis in the following format:
TYPE: <one of the following values>
- NO_QUESTION
- SINGLE_QUESTION
- SINGLE_QUESTION_WITH_ANSWER
- MULTIPLE_QUESTIONS
- MULTIPLE_QUESTIONS_WITH_ANSWERS
system
This article is a collaboration between MedPage Today® and:
Boston Scientific said its Synergy bioabsorbable polymer drug-eluting stent is the first such device to receive marketing approval from the FDA.
In a statement, the company said the FDA approval was based on results from the EVOLVE II trial, which were reported in November 2014 at the American Heart Association meeting.
The study assigned 838 patients to receive the PROMUS Element Plus drug-eluting stent and 846 patients to receive the Synergy stent. More than two-thirds of the patients were men and the average age was 63.
In a per protocol analysis, EVOLVE II demonstrated noninferiority (P =0.003) with 6.4% of the Synergy patients and 6.4% of controls experiencing the target vessel failure at 12 months.
"Boston Scientific will continue to advance the robust clinical program supporting the SYNERGY Stent with the initiation of the EVOLVE Short Dual Anti-Platelet Therapy (DAPT) Study, expected during the first quarter of 2016. The company has received an Investigational Device Exemption (IDE) for this prospective study designed to assess the safety of 3-month use of DAPT in patients at high risk for bleeding undergoing percutaneous coronary intervention (PCI) with the SYNERGY Stent," the company said in its press release.
The stent "features ultrathin stent struts with an abluminal bioabsorbable drug/polymer coating technology that is absorbed shortly after drug elution is complete at 3 months, thereby eliminating long-term polymer exposure."
Synergy was approved for use in Europe in 2012.
While Synergy features a bioabsorbable polymer, the "holy grail" in the stent world is a fully bioabsorbable platform. Last month, that bioabsorbable technology was featured at the European Society of Cardiology, with latest findings from Abbott Vascular Technology's Absorb stent. At that time, ABSORB investigator Patrick W. Serruys, MD, PhD, told MedPage Today that progress with resorbable technology has been slow, but steady.
user
The text is a press release and article summary about the FDA approval of Boston Scientific's Synergy bioabsorbable polymer drug-eluting stent, including details about the clinical trial that led to its approval and future studies planned for the device.

TYPE: NO_QUESTION