SAN FRANCISCO–(BUSINESS
WIRE)–Cappella Medical Devices Ltd (Cappella), a medical device
company developing dynamic solutions for the treatment of coronary bifurcation
disease, announced today at the 2011 TCT (Transcatheter Cardiovascular
Therapeutics) Conference in San Francisco results from several long term
studies of its Sideguard® technology. These studies document the need to treat
coronary bifurcation disease with a dedicated sidebranch system versus the
traditional provisional approach.
One study being presented this week includes the results of
the Cappella Sideguard multicenter European Registry that included data on 125
patients from 9 institutions. This data was compared retrospectively to data
from the current practice of provisional stenting in 125 bifurcations. The
study concluded that sidebranch protection with the Sideguard device reduces
sidebranch failure in comparison to provisional stenting. The investigators
conclude that the Sideguard dedicated bifurcation stent could facilitate
bifurcation PCI and make the procedure more predictable and safe. One of the
investigators of the study from San Raffaele Scientific Institute in Milan, Italy,
Dr. Azeem Latib, stated, “We are excited to share this data on the Sideguard
technology documenting its benefits versus the existing provisional technique.
Clinical data is important for any technology to be utilized and we look
forward to building on this initial finding with ongoing trials to validate the
need for dedicated bifurcation technology.”
Another new study being presented this week is the long term
follow up study of 61 patients from a single hospital (Manchester Heart Centre,
Manchester, UK). This study concludes that the
Sideguard system can be used to treat bifurcation lesions in a straightforward
manner with excellent short and long term clinical outcomes. Dr. Farzin
Fath-Ordoubadi, Consultant Cardiologist and Cath Lab Director at the Heart
Centre, Manchester Royal Infirmary commented, “This study has shown that the
Sideguard technology is not subject to some of the limitations associated with
conventional bifurcation PCI techniques including the inability to fully cover
the ostium of the sidebranch, maintaining wire access to the main vessel, and
protecting the sidebranch at all times. The dedicated Sideguard system is a
unique technology that overcomes limitations of other bifurcation treatment
options.” The data from these studies is expected to be published early next
year.
Many patients have to return for a follow up PCI procedure
for various reasons. Some of those reasons may be related to the fact that the
sidebranch is not fully protected (including the ostium) during a conventional
provisional bifurcation procedure. This lack of protection may result in plaque
redistribution and/or carina shift that may necessitate the need for another
procedure. Art Rosenthal, PhD, Executive Vice Chairman of the Board and
President of Cappella R&D, stated, “Todays current techniques to treat
bifurcation disease all have limitations in terms of ostial protection and
sidebranch preservation. These studies are validating the need for a system
designed specifically for the unique challenges of coronary bifurcations. We
are confident that the positive results being presented this week at TCT are in
part due to the Sideguard platform that scaffolds the ostium reducing plaque
and carina shift while preserving the sidebranch.”
About Cappella Medical Devices
Cappella, Inc. is a medical device company that develops novel solutions for
the treatment of complex coronary artery disease (CAD) focused on protecting
the coronary sidebranch arteries. Cappellas Sideguard® coronary sidebranch
technology offers interventional cardiologists a straightforward, effective,
and easy to use solution that preserves the sidebranch of diseased coronary
arteries by protecting the ostium while minimizing plaque shift. The Sideguard
delivery system features a proprietary split-sheath, balloon released,
technology that ensures precise placement on the ostial borderline. The
Sideguard self-expanding, nitinol, stent promotes continuous wall apposition
and positive remodelling and its unique trumpet-shaped design conforms to
varying characteristics of the sidebranch ostium. The Cappella Sideguard system
is currently CE mark approved and is being distributed throughout Europe and South America. Cappella Medical Devices Ltd., Galway, Ireland
is the R&D and manufacturing subsidiary of Cappella, Inc. For more
information, please visit the Cappella Medical Systems website at www.cappella-med.com.
