Advanced delivery system gives physicians more control to achieve consistent vascular closure
ST. PAUL, Minn.--(BUSINESS WIRE)--
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and
Drug Administration (FDA) and European CE Mark approval of the
Angio-Seal(TM) Evolution(TM) Vascular Closure Device. The approval and
global launch was announced at the Transcatheter Cardiovascular
Therapeutics conference in Washington, D.C.
The Angio-Seal Evolution device is designed to enable physicians
to quickly and effectively seal femoral artery punctures made during
minimally invasive catheter-based procedures. Effectively sealing the
puncture helps achieve hemostasis (cessation of bleeding) quickly,
enabling the patient to walk and resume activities sooner.
The Angio-Seal Evolution platform features an entirely new
delivery system that significantly reduces the variability that can
occur as physicians deploy and secure the Angio-Seal closure system.
Consistent with its Angio-Seal predecessors, Angio-Seal Evolution
achieves hemostasis through the deployment of an anchor, suture and
collagen seal (each of which is bioabsorbable). With Evolution,
however, single-handed deployment has been made possible for the first
time, which enables physicians to more easily support the puncture
site. The new device's automated collagen compaction system ensures
consistent compaction of the collagen against the exterior wall of the
vessel reducing procedural variables. With fewer variables in device
deployment, physicians gain greater control and consistency in
achieving rapid, safe and reliable hemostasis for their patients.
"The Angio-Seal Evolution takes a major step forward by
automatically compacting the collagen," said Robert J. Applegate,
M.D., Wake Forest University Baptist Medical Center, Winston-Salem,
N.C. "The confidence it provides physicians in closing the puncture in
such a short period of time with such effectiveness is outstanding."
More than 13 million catheterizations are performed worldwide each
year to open narrowed or blocked arteries and perform other
cardiovascular procedures. During catheterizations, physicians insert
a catheter (a thin tube) through a puncture made in the femoral artery
in the upper thigh and guide it through the blood vessels to the point
of care. Treatments such as balloons, stents and medications are then
delivered through the catheter. Once a procedure is complete and the
catheter is removed, bleeding from the puncture in the femoral artery
must be stopped quickly.
Unlike most vascular closure devices, the Angio-Seal Evolution
closure system is fully absorbed by the body within 60 to 90 days.
This reduces risks associated with foreign material left permanently
in the body and allows for repeat procedures without concerns about
prior placement of closure devices.
"The Angio-Seal Evolution embodies St. Jude Medical's commitment
to providing physicians with more control over patient outcomes while
reducing procedural variability," said Frank J. Callaghan, president
of the St. Jude Medical Cardiovascular Division. "We are confident the
Evolution platform will further enhance Angio-Seal's position as the
recognized leader in vascular closure and provide physicians with
increased confidence in the ease of device deployment and
Prior to Angio-Seal, patients were required to endure 15 to 30
minutes of manual pressure at the catheter's access site in the leg,
followed by four to 12 hours of bed rest to ensure that hemostasis was
maintained. Most patients treated with Angio-Seal devices report
significantly less discomfort after a catheterization and are able to
resume normal activity more quickly. When Angio-Seal devices are used
to seal vascular punctures made to diagnose cardiovascular conditions,
most patients are able to walk within 20 minutes and leave the
hospital one hour later.
Angio-Seal closure devices also increase hospital productivity and
efficiency by reducing the length of patient stays in the
catheterization lab or recovery area, thus providing potential cost
St. Jude Medical is the market leader in vascular closure devices.
More than 11 million Angio-Seal devices have been distributed around
the world since 1994 and in excess of 325 studies have documented the
benefits of Angio-Seal devices to physicians, patients and hospitals.
About St. Jude Medical
St. Jude Medical develops medical technology and services that
focus on putting more control into the hands of those who treat
cardiac, neurological and chronic pain patients worldwide. The company
is dedicated to advancing the practice of medicine by reducing risk
wherever possible and contributing to successful outcomes for every
patient. Headquartered in St. Paul, Minn., St. Jude Medical employs
more than 13,000 people worldwide and has five major focus areas that
include: cardiac rhythm management, atrial fibrillation, cardiac
surgery, cardiology and neuromodulation. For more information, please
This news release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that
involve risks and uncertainties. Such forward-looking statements
include the expectations, plans and prospects for the Company,
including potential clinical successes, anticipated regulatory
approvals and future product launches, and projected revenues,
margins, earnings, and market shares. The statements made by the
Company are based upon management's current expectations and are
subject to certain risks and uncertainties that could cause actual
results to differ materially from those described in the
forward-looking statements. These risks and uncertainties include
market conditions and other factors beyond the Company's control and
the risk factors and other cautionary statements described in the
Company's filings with the SEC, including those described in the Risk
Factors and Cautionary Statements sections of the Company's Annual
Report on Form 10-K filed on February 27, 2008. The Company does not
intend to update these statements and undertakes no duty to any person
to provide any such update under any circumstance.
Source: St. Jude Medical, Inc.