October 29, 2008 - Nearly 18 months of data from Cappella’s Sideguard I and II self-expanding side branch heart stent in-man trials were released Oct. 13 at TCT, marking an important milestone for Cappella.
The Sideguard I and II trials enrolled 85 patients with significantly diseased coronary arteries - 96 percent had vascular disease involving the side branch. Seventy-five of the patients were successfully implanted with the Sideguard stent, and after 30 days, the major adverse cardiac Events (MACE) rate was 4.8 percent and 4 percent respectively. So far, MACE data on 50 and 45 patients is available, at 12 and 11.1 percent. There were no deaths, two early myocardial infarctions and incidences of stent thrombosis within the stented area. Only three patients were brought back for re-treatment.
In addition results from the Sideguard I and II first-in-man trials came Intravenous Ultrasound (IVUS) data, presented by Gary Mintz, M.D., of the Cardiovascular Research Foundation, NY, NY. The results were very positive, even though the IVUS subset consisted of a small number of patients (11/49). The most significant finding was the increase of the coronary stent area (CSA) where the Sideguard stent was implanted. At the six-month IVUS follow-up, the stented area increased from 3.9 mm to 4.6 mm. The Sideguard investigators believe this is attributed to the nature of the self-expanding design of the stent, which is in constant expansion. More data is needed to confirm these findings, the company said.
On Oct. 16, Cappella conducted two live cases via satellite from the HELIOS Heart Center in Siegburg, Germany and the OLV Hospital in Aalst, Belgium.
“The learning curve (associated with Sideguard) is pretty short. I am confident that by using the Cappella device and gathering more experience (using Sideguard), usage of the device will certainly increase,” said Emanuele Barbato, M.D., Ph.D, Cardiovascular Centre Aalst.
The live case was only Dr. Barbato’s second, which is a testament to the device’s ease of use, the company said. The other Cappella live case was performed by veteran Sideguard operator and Sideguard clinical trial principal investigator, Prof. Eberhard Grube, M.D. from the HELIOS Heart Center in Siegburg, Germany.
The Sideguard OPD and Target SE Balloon-Expandable Delivery Catheter system were developed by Cappella Medical Devices Ltd., Galway, Ireland, a subsidiary of Cappella Inc., Auburndale, MA. The Cappella Sideguard OPD is an anatomically-shaped, self-expanding nitinol coronary stent designed to conform to the varying anatomies located at the bifurcation point of an artery. The Target SE delivery catheter is a unique balloon-expandable device specifically developed for the deployment of self-expanding stents. Target SE is entirely manufactured and assembled in Galway Ireland.
For more information: www.cappella-inc.com