New Providence, NJ's Svelte Medical announced the European launch of the Slender IDS drug-eluting stent, claiming it is the lowest profile device of its kind, resulting in smaller delivery catheter and easier implantation. The device elutes the drug sirolimus.
 |
| Slender IDS in a blood vessel.--Courtesy Svelte Medical |
The so-called Discreet drug coating also contains a proprietary natural, amino acid-based polyesteramide bioresorbable drug carrier made by DSM Biomedical.
Other features of the stent and its integrated implantation (or delivery) system include specialized guidewire made by Asahi and so-called Balloon Control Band to allow controlled balloon growth during stenting and high-pressure post-dilatation.
But the most important feature is the low profile, or the diameter of the stent prior to its installation and expansion in the coronary artery. The low profile allows installation of the device through the slender transradial artery, beginning in the patient's wrist.
"Downsizing is the future of interventional cardiology, and Slender IDS is the first ultra-low profile DES (drug-eluting stent). The ability to reduce catheter size without compromise to performance minimizes vascular trauma and enables use of the transradial approach, with all of its well-known clinical benefits, across broader subsets of patients. This makes for a much more pleasant patient experience," Dr. Giovanni Amoroso, an interventional cardiologist OLVG Hospital in Amsterdam, said in a statement.
Amoroso will be the principal investigator of a European postmarket study to evaluate procedural efficiencies and 12-month clinical outcome. The company plans to conduct an FDA clinical trial for U.S. approval via the stringent PMA pathway, hoped for in 2016.
- read the release