BridgePoint Medical® Receives European CE Mark for
Stingray® and CrossBoss™ for Opening Completely Blocked Arteries
Minneapolis, Minnesota, November 20th, 2009 — BridgePoint Medical announced
today that it received European CE Mark (Conformité Européene) for its coronary
and peripheral Chronic Total Occlusion (CTO) Crossing System comprised of the
CrossBoss™ CTO Crossing Catheter and the Stingray® 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.
Contact
Chad Kugler
President and General Manager
BridgePoint Medical, Inc
763-225-8500
