Automated irrigation pump provides control over fluid delivery during radiofrequency (RF) catheter ablation procedures
ST. PAUL, Minn.--(BUSINESS WIRE)--Jun. 17, 2009--
St. Jude Medical, Inc. (NYSE:STJ) today announced U.S. Food and Drug
Administration (FDA) approval of its Cool Point™ Irrigation Pump. Used
in conjunction with SJM open-irrigated ablation catheters, an irrigation
pump supplies a continuous flow of saline through the catheter’s inner
lumen to cool the ablation electrode for more effective energy delivery.
Designed to enhance physicians’ ability to perform successful atrial
ablations, the new Cool Point irrigation pump was developed specifically
for use with the company’s IBI-1500T9-CP cardiac ablation generator and
family of Therapy™ Cool Path™ irrigated catheters.
“The Cool Point pump is part of a fully integrated system that has been
designed for easy set up and seamless operation with our latest cardiac
ablation generator and our growing family of Therapy Cool Path
open-irrigated catheters,” said Jane J. Song, president of the St. Jude
Medical Atrial Fibrillation Division. “By introducing the Cool Point
Irrigation Pump, we provide plug-and-play connectivity with the lab’s
existing St. Jude Medical equipment.”
In addition to the intuitive setup and operation, the Cool Point
Irrigation Pump provides monitoring and safety features, which are
designed to give physicians more control over therapy delivery. This
interface enables physicians to monitor the total volume of irrigation
solution delivered through an easy-to-read display.
The pump’s proprietary tubing includes an in-line occlusion detector,
which monitors flow pressure between the pump and the catheter tip,
providing an alert if flow pressure increases substantially relative to
the flow rate (an indication that irrigation ports on the catheter tip
may be blocked and the tip cooling may not be effective). In addition,
the pump has redundant bubble detectors, each designed to detect bubbles
as small as two microliters. Bubbles in the bloodstream may lead to
embolism or stroke.
Catheter ablation therapy is used by physicians to restore a normal
heart rhythm in patients with, typical atrial flutter. During cardiac
ablation, an electrophysiologist (EP) uses a catheter (a thin, flexible
tube) to deliver energy that creates lesions in specific areas of
cardiac tissue. The lesions, or tiny scars, interrupt the abnormal
electrical signals that contribute to erratic heart rhythms.
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 approximately 14,000 people worldwide and has
four major focus areas that include: cardiac rhythm management, atrial
fibrillation, cardiovascular and neuromodulation. For more information,
please visit www.sjm.com.
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 Quarterly Report on Form 10-Q for
the fiscal quarter ended April 4, 2009. 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.
St. Jude Medical, Inc.
Amy Jo Meyer, 651-756-3029