August 6, 2008
St. Jude Medical Announces Japanese Approval of the Durata Defibrillation Lead
St. Jude Medical, Inc. (NYSE:STJ) today announced regulatory approval, in addition to reimbursement approval, from the Japanese Ministry of Health, Labour and Welfare (MHLW), for the Durata(TM) defibrillation lead, the company's next-generation high-voltage lead.
The Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle (RV) shock coil intended to enhance ease of use and handling for physicians implanting an ICD (implantable cardioverter defibrillator) system in patients at risk for dangerously fast heart rhythms. The Durata lead also incorporates Optim(R) insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads. Optim insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation.
The Durata lead is the same size as the company's Riata(R) ST Optim(TM) lead which, at 7 French, is the smallest diameter high-voltage lead on the market. Small diameter leads may be especially helpful for patients with compromised blood flow, a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel.
"The Durata lead represents St. Jude Medical's commitment to continuous innovation and improvement, incorporating new features based on physician feedback to better serve our physician customers and their patients," said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. "This new lead combines next-generation technology with features designed to increase reliability and long-term durability and thereby reduce risks."
St. Jude Medical(R) Durata leads have additional exclusive features including:
-- Flatwire technology with complete silicone backfill designed to prevent tissue in-growth.
-- Dual, redundant cables designed to increase reliability, so that if one cable is damaged another will provide backup.
-- Single- and dual-coil design with 17 cm and 21 cm shock coil spacing, which gives physicians more options when selecting the most appropriate lead for individual patient anatomy.
"The expansion of our high-voltage product offerings in Japan with these state-of-the-art leads will help us meet the needs our physician customers around the world," said Paul Bond, chairman of St. Jude Medical Japan Co., Ltd.
A lead is a thin insulated wire that is placed through the vein as part of a pacemaker or ICD implantation procedure. Its tip is attached to the heart tissue, and its other end connects to the pacemaker or ICD. A lead carries electrical impulses from the pacemaker or ICD to the heart and transmits information from the heart back to the implanted device.
An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (known as ventricular tachycardia or ventricular fibrillation) by delivering energy to the heart through an insulated wire or lead. Defibrillation leads also have the ability to sense disruptions to a patient's heartbeat, and transmit these impulses back to the ICD to determine whether the potentially life-saving therapy should be delivered.
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 12,500 people worldwide and has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology 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 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.