BridgePoint Medical(R) Receives European CE Mark for Stingray(R) and CrossBoss(TM) for Opening Completely Blocked Arteries
By Bridgepoint Medical Inc., PRNESunday, November 22, 2009
MINNEAPOLIS, November 23 - BridgePoint Medical announced today that it received European CE Mark
(Conformite Europeene) for its coronary and peripheral Chronic Total
Occlusion (CTO) Crossing System comprised of the CrossBoss(TM) CTO Crossing
Catheter and the Stingray(R) CTO Re-Entry System. The BridgePoint System is a
series of interventional catheters that are designed to navigate highly
diseased arteries in preparation for blood flow restoration via angioplasty
and stenting.
The National Heart, Lung and Blood Institute (NHLBI) estimates that
Chronic Total Occlusions (CTOs) are common and are found in approximately
one-third of patients who undergo angiography, which equates to a world wide
annual incidence of 1.3 million patients. Interventional cardiologists are
currently unable to broadly treat patients with chronic total occlusions due
to the procedurally challenging and advanced nature of the disease. For these
patients, alternatives include bypass surgery or pharmacologic therapy. For
the millions of people with living with a coronary CTO, chest pain, shortness
of breath and fatigue are part of every day life.
"We have seen many attempts to implement new tools for the treatment of
chronic coronary occlusions over the years, but until now none of them have
provided any advantage over the current treatment of using specialty
guidewires," said Gerald Werner M.D. Ph.D., Professor at the Klinikum
Darmstadt in Darmstadt, Germany. "This system is the first to provide a new
option for the frequent situation when our guidewires do not reach the vessel
beyond the occlusion. The BridgePoint system makes it possible to find the
true vessel lumen and conclude the treatment successfully."
The disposable BridgePoint Catheter System does not require the use of
expensive and cumbersome capital equipment and uses techniques that are
common in interventional medicine.
"The CrossBoss and Stingray devices provide interventionalists in the
E.U. with new opportunities to treat patients with highly diseased arteries.
We believe that these devices represent an important new advance in
interventional cardiology," said Chad Kugler, Co-Founder, President and
General Manager, BridgePoint Medical. "This technology exemplifies
BridgePoint's innovative approach to CTO treatment and our commitment to
further reduce the need for invasive bypass surgery."
The BridgePoint Medical CrossBoss and Stingray are indicated in the
European Union for adults with coronary or peripheral artery disease, age 18
and older. The devices are contraindicated for use in cerebral vasculature.
Clinical Trial Summary
In a prospective clinical trial conducted in the European Union and a
post-market registry conducted primarily in South America the BridgePoint
System was 67%-85% successful in placing an interventional guidewire beyond a
chronic total coronary occlusion. Complications with the system were similar
to general PCI and stenting.
The BridgePoint devices are currently under clinical investigation in the
U.S. and are not commercially available for treating CTO in the U.S.
About Chronic Total Coronary Occlusions
The National Heart, Lung and Blood Institute (NHLBI) estimates that
Chronic Total Occlusions (CTOs) are common and are found in approximately
one-third of patients who undergo angiography. Patients surviving with a CTO
commonly suffer from poor blood circulation to the heart muscle that induces
symptoms such as chest pain (angina), shortness of breath and fatigue.
Studies also show that the patients living with an untreated coronary CTO are
at higher risk of death.
About BridgePoint Medical
BridgePoint Medical, Inc. is a privately held company established in 2006
to design, develop and commercialize new technologies and techniques to treat
challenging coronary artery disease. Investors include New Enterprise
Associates, Polaris Venture Partners, Foundation Medical Partners and Michael
Berman.
Chad Kugler, President and General Manager of BridgePoint Medical, Inc., +1-763-225-8500
Tags: Bridgepoint Medical Inc., France, Germany, Minneapolis, Minnesota, United Kingdom