BridgePoint Medical(R), Inc. Completes and Submits to FDA in the U.S. FAST-CTOs With the CrossBoss(R) and Stingray(R) CTO Recanalization System
By Bridgepoint Medical Inc., PRNESunday, October 3, 2010
MINNEAPOLIS, October 4, 2010 - BridgePoint Medical, Inc., a medical device company focused on coronary
and peripheral catheter-based systems for chronic total occlusion (CTO)
recanalization, announced the completion of the FAST-CTOs study.
BridgePoint's 16 center, 147 patient U.S. FAST-CTOs (Facilitated Antegrade
Steering Technique for the treatment of Chronic Total Occlusions) study was
designed to assess the safety and effectiveness of the CrossBoss and Stingray
devices in chronically occluded coronary arteries.
Chad Kugler, President and General Manager of BridgePoint said, "The
trial was extremely well executed by our study investigators. Follow-up and
data collection was completed for our FAST-CTOs patients in August and we
filed a request for an indication expansion of our 510(k) clearance at the
end of September."
The FAST-CTOs data were unveiled to the interventional community at the
TCT conference in Washington, D.C., by study investigator R. Michael Wyman
MD. Wyman highlighted a 77% overall effectiveness of the BridgePoint CTO
recanalization system in patients that were refractory to the current
standard of care. In addition, the data show that crossing success
accelerated to 86% in the last half of the trial as investigators became more
facile with the devices and associated techniques. Wyman highlighted that the
FAST-CTOs study included more difficult (longer length) total occlusions
while achieving a significantly higher success rate and lower adverse event
rate as compared to other CTO clinical trials.
"In coronary CTO revascularization, operator technique and new guidewire
technology have lead to modest improvement in short term antegrade success
over the last decade, and drug-eluting stents have dramatically improved
long-term durability. Despite these advances attempt rates remain low and the
presence of a CTO remains the primary reason for referral of a patient to
bypass surgery," commented Patrick Whitlow MD, FAST-CTOs study principal
investigator. "The high success rate in very long, difficult CTO cases found
with the CrossBoss and Stingray in FAST-CTOs represents a major step forward
and a new standard in CTO intervention. The safety of the devices and
intuitive ease of use coupled with the remarkable success should expedite
rapid adoption of these new devices into clinical practice."
About the PFAST-CTOs Peripheral Trial
Also today, BridgePoint announced that it received approval from the
United States Food and Drug Administration (FDA) to start the PFAST-CTOs
study (Peripheral Facilitated Antegrade Steering Technique for the treatment
of Chronic Total Occlusions). The 50 patient 10 center trial is intended to
assess the safety and effectiveness of the BridgePoint recanalization system
in lower extremity CTOs.
About CrossBoss and Stingray
The BridgePoint CTO recanalization system used in both studies includes
an over-the-wire CrossBoss Catheter delivered over standard guidewires to the
site of a chronic total occlusion. The blunt tip CrossBoss Catheter utilizes
the Fast-Spin technique to facilitate crossing of CTOs along true lumen or
subintimal pathways. The Stingray Catheter is an over-the-wire re-entry
system allowing true lumen access from a subintimal plane. In concert, the
system allows subsequent revascularization by debulking, balloon angioplasty
and stent placement. For many patients, this minimally invasive, endovascular
approach to CTO recanalization may eliminate the need for invasive bypass
surgery and chronic reliance on pharmacologic therapy.
About Chronic Total 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
coronary 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. Patients with lower extremity CTOs
often suffer from poor circulation in the legs often resulting in
debilitating leg pain (claudication), limb threatening ischemia, and limb
amputation.
About BridgePoint Medical
BridgePoint Medical, Inc. is a privately held company established in 2006
to design, develop and commercialize new technologies to treat challenging
coronary and peripheral artery disease. Investors include New Enterprise
Associates, Polaris Venture Partners, Foundation Medical Partners and Michael
Berman. Additional information is available on the company's website at
www.bridgepointmedical.com.
Chad Kugler of BridgePoint Medical, Inc., +1-763-225-8500
Tags: Bridgepoint Medical Inc., Minneapolis, Minnesota, October 4, Western Europe