St. Jude Medical Announces FDA 2nd European CE Mark Approvals Of Tendril ST(R) Pacemaker Lead
The Tendril ST lead is one of the thinnest pacing leads on the market, using low-profile, flat-wire technology to reduce the size of the outer coil and lead body. The thin diameter makes it easier for physicians to implant, but still allows for excellent visibility so physicians can track the lead's movement through the vein.
The Tendril ST lead also offers advanced technology that enables physicians to save time during implants, and causes less disturbance to heart tissue by allowing the lead to take crucial measurements (such as threshold and sensing diagnostics) to ensure that the lead is in the correct position before fixating the lead to the heart.
A lead is an insulated wire that is placed through the vein as part of a pacemaker implantation procedure. Its tip is fixated to the heart tissue, while its other end connects to the pacemaker. A lead carries electrical impulses from the pacemaker to the heart and transmits information from the heart back to the implanted device.
"The new Tendril ST lead is important because, in this day and age with multiple leads being implanted in one vein, it is vital to preserve venous space," said Steven Hao, M.D., Marin General Hospital/California Pacific Medical Center, San Francisco, Calif. "This thin lead is the thinnest extendable/retractable active-fixation lead to fit in a 6 F introducer that I have used to date," said Hao, citing the equipment used to introduce a lead in a vein.
The Tendril ST lead offers physicians the flexibility of lead placement in the heart's upper chamber (atrium) or lower chamber (ventricle). The lead is available in 46, 52, 58, and 65 cm lengths to give physicians more choices in addressing the individual needs of patients with varying physical statures and vascular anatomies.
The Tendril ST lead also features:
New stylet options to accommodate a range of physician preferences. A stylet is a thin wire used to provide support when implanting a lead. Fast-Pass® coating, a lubricious coating on the outside of the lead that facilitates lead insertion through the introducer and the veins. This coating helps reduce lead body surface friction, allowing multiple leads to easily move against one another and reducing the chance of inadvertently moving one lead during the manipulation of another. About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 11,000 people worldwide. For more information, please visit www.sjm.com.
Forward-Looking Statements
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, regulatory approvals, anticipated future product launches, 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 Company's Annual Report on Form 10-K filed on March 16, 2006 (see Item 1A on pages 15-21) and in the Company's Quarterly Report on Form 10-Q filed on August 7, 2006 (see page 31 and Item 1A on page 32). The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.
Contact: St. Jude Medical, Inc., St. Paul Investor Relations: Angela Craig, 651-481-7789 or Media Relations: Kathleen Janasz, 651-415-7042
Source: St. Jude Medical, Inc.