Svelte Medical Systems has received CE mark to market Acrobat Stent-on-a-Wire (SOAW) Bare Metal Coronary Stent System in the European Union (EU).
Svelte Medical claimed that its Acrobat SOAW allows reduced use of contrast medium and reduces operator and patient radiation dosing, which ultimately benefits the patients.
The various clinical trials proved that Acrobat SOAW facilitate direct stenting and can provide substantial procedural time and cost savings, said the company.
Currently, Svelte Medical is planning to start Acrobat SOAW technology US clinical trial in 2011.
Svelte Medical president and CEO Mark Pomeranz said that they have successfully completed the first-in-man (FIM) clinical evaluations at the end of July and with receipt of the CE mark they will be able to make this product commercially available to a broad range of physicians and patients
“Distribution of the Acrobat stent within the EU and Brazil will commence in September. We feel confident that the market will respond positively and that the Acrobat will gain a significant share of the market for coronary stents,” Pomeranz said.