News | October 29, 2008

New Cappella Sideguard Heart Stent Shows Promise in Trials

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

Related Content

The TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

The presentation of the ESC late-breaker TIDES-ACS results show us that the Optimax stent is noninferior in patients with acute coronary syndrome compared to Synergy.

News | Stents| November 24, 2017
November 24, 2017 – During a late-breaking session at the European Society of Cardiology (ESC) 2017 meeting, presente
News | Stents| November 10, 2017
Cordis, a Cardinal Health company, recently unveiled a comprehensive interventional cardiology portfolio, which now...
OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

OCT comparison between the Combo vs. Xience stents in the HARMONEE study.

Feature | Stents| November 08, 2017
November 8, 2017 – New results from the HARMONEE Japan/U.S.
FDA Approves COBRA REDUCE Trial of 14-Day DAPT With CeloNova Stent
News | Stents| October 27, 2017
CeloNova BioSciences Inc. announced the U.S. Food and Drug Administration (FDA) approved expansion of CeloNova's...
CeloNova Cobra Pzf stent
Technology | Stents| March 02, 2017
March 2, 2017 — The U.S. Food and Drug Administration (FDA) cleared CeloNova BioSciences Inc.
OCT, intravascular imaging, stent, good stent apposition on vessel wall, TRANSFORM-OCT study

An OCT image showing good stent strut apposition against the vessel wall.

News | Stents| January 13, 2017
January 13, 2017 — Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
EXCEL Trial, TCT 2016, drug-eluting stents, CABG, surgery left main heart disease, LMCAD

Gregg W. Stone, M.D., presenting the EXCEL data at TCT 2016 during a standing room only late-breaking trial session.

Feature | Stents| January 12, 2017 | Dave Fornell
The biggest news from the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting this past fall was the results
Biotronik's Osiro stent, prison IV trial

Biotronik's Osiro ultra-thin strut, sirolimus-eluting stent.

News | Stents| November 09, 2016
November 9, 2016 – Results from a randomized, multicenter trial failed to show non-inferiority of hybrid, ultra-thin
OCT stent strut coverage

OCT imaging showing neointimal tissue coverage of metallic stent struts.

News | Stents| November 07, 2016
November 7, 2016 – Results from TRANSFORM-OCT, a prospective, randomized trial using optical coherence tomography (OC
biosensors Biofreedom stent
News | Stents| November 07, 2016
November 7, 2016 – The two-year results from LEADERS FREE, the first randomized clinical trial dedicated to high blee
Overlay Init