Healthcare Industry News:  neuromodulation 

Devices Cardiology

 News Release - June 10, 2009

St. Jude Medical Announces Initial Implant of First-to-Market Connector System in the U.S.

New Streamlined Design Expected to Offer Implanting Physicians a More Efficient Procedure and Improve Patient Comfort

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced the first implant of its Current(R) Plus implantable cardioverter defibrillator (ICD), featuring the SJ4 connector system. The St. Jude Medical SJ4 connector reduces the number of connections between the device and the wires (defibrillation leads) that send electrical impulses to the heart, which is intended to enable a streamlined implant procedure.

The SJ4 connector system features a single connection between the device and the defibrillation lead, and a single set screw (used to tighten and secure the lead to the device). Previous defibrillator lead designs required three separate connections and four set screws. The reduced number of lead connections also lessens the risk of lead-to-can abrasion, a known complication that can occur in patients who have an implantable device.

“With only a single connection and one set screw, the SJ4 connector has the potential to improve the implant procedure, may reduce the lead volume under the ICD in the chest wall and may improve patient comfort,” said Cleveland Clinic’s Bruce Wilkoff, M.D., who is on the company’s physician lead review board and has sponsored research with St. Jude Medical, Inc. Dr. Wilkoff implanted the first Current Plus ICD with SJ4 connector on June 4, 2009. “This design is intended to reduce the risk of incorrect connections of the lead to the ICD and reduce procedure time.”

The St. Jude Medical SJ4 connector system is designed to meet the draft IS-4 standard as set forth by the International Organization of Standardization (ISO) but will not be labeled as such until the standard is finalized, which is expected later this year. St. Jude Medical began launch of the SJ4 connector system after ISO-directed interchangeability testing among multiple manufacturers was completed. This testing was deemed an important step in ensuring that these new leads, which currently meet the drafted IS-4 standard, would be compatible with future implanted devices.

“Simplifying the lead connection process is one of many design features we have incorporated as part of our commitment to making procedures safer for patients and more efficient for physicians, from implant through follow-up,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “This aligns with our strategy of reducing lead risks and increasing reliability, which includes technology designed to reduce lead-to-can abrasion and sensing of far-field ventricular signals in the atrium.”

The Current Plus ICD was approved by the FDA in April 2009, along with the company’s Promote(R) Plus cardiac resynchronization therapy defibrillator (CRT-D), which are compatible with the Durata(R) SJ4 defibrillation lead. As with previously announced leads in the Durata lead family, the Durata lead with SJ4 connector features a soft silicone tip and Optim(R) insulation, a hybrid insulation material that provides increased abrasion-resistance and durability, along with the flexibility and handling characteristics that facilitate device implantation.

Both devices are built on the St. Jude Medical Unity platform, a consolidated hardware and software unified device interface, and include advanced safety features and algorithms for improved patient management, including TailoredTherapy™ features that allow physicians to customize therapy to individual patient needs. The devices also feature improved lead monitoring capabilities, including daily checks of all pacing and shock configurations, and have the ability to inform the patient’s clinic, via the St. Jude Medical Merlin@home(R) transmitter and Merlin.net™ Patient Care Network (PCN), of any critical system changes.

As a requirement for FDA approval, St. Jude Medical is conducting a post-approval study featuring the SJ4 connector that will enroll up to 1,700 patients and follow them for five years. The company will also be gathering data on this new connector system as part of its ongoing SCORE patient registry, designed to track long-term data on system performance for all products, including new technology.

A defibrillation lead is a long insulated wire that serves as a conduit between an implanted device and the heart. The lead sends electrical signals from the device to the heart to provide therapy needed to address abnormal heart rhythms. The lead also carries information from the heart back to the implanted device, where the data can be used by the device to deliver therapy or make automatic adjustments, and used by physicians to determine optimal device settings and therapies for each patient.

An ICD is a small device implanted in the chest to treat potentially lethal, abnormally fast heart rhythms (ventricular tachycardias or ventricular fibrillation), which often lead to sudden cardiac death (SCD). Nearly 1,000 people every day and more than 350,000 every year in the U.S. die from SCD. An ICD delivers potentially life-saving therapy from the device to the patient's heart through an insulated wire or lead.

Cardiac resynchronization therapy - delivered in an ICD or a pacemaker - resynchronizes the beating of the heart's lower chambers (ventricles), which often beat out of sync in heart failure patients. Studies have shown that CRT can improve the quality of life for many patients with heart failure, a progressive condition in which the heart weakens and loses its ability to pump an adequate supply of blood. About 5 million Americans suffer from heart failure, with 550,000 new cases diagnosed every year, according to the American Heart Association.

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.

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, 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

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