Boston Scientific, a global medical device manufacturer based in Natick, Massachusetts, announced that it has successfully enrolled a patient in an Evolve II trial of the company’s Synergy stent. The Synergy drug-eluting stent is used for the delivery of targeted medications. With data from the clinical trial, the company hopes to provide further backing for its approval applications in Japan and the United States.
The company’s Synergy stent is coated with a specialized polymer with bioabsorbable properties. The coating on the stent is designed to absorb everolimus, a potent chemotherapy drug. Once in the body, everolimus will be eluted front the stent for up to 90 days. According to a press release by the company, the clinical trial will comprise 2,000 patients and will last for at least five years.
Kevin Ballinger is the interventional cardiology president at Boston Scientific. In prepared remarks, he said, "We continue to strengthen our drug-eluting stent portfolio with innovations like the Synergy system in an effort to increase the advanced treatment options available to physicians and patients." He continued, "This underscores our commitment to the drug-eluting stent market and reinforces our position as a global market leader."
The upcoming clinical trial of the company’s Synergy drug-eluting stent follows CE Mark approval of the device. With approval by the European Union, the company plans to start a commercial rollout of the new stent technology as soon as 2013.
- When Do I Really Need to Perform an Ethylene Oxide Requalification? - Webcast
- Rapid Prototyping for Medical Devices - Webcast
- New Approaches to Assessing Biocompatibility for Medical Devices - Webcast
- Five Mistakes That Can Derail Your Product Development Effort - Webcast
- How to Manage Risk Throughout Medical Device Product Development Cycle and Beyond - Webcast
- Common Mistakes to Avoid During Medical Device Product Development - Webcast