Healthcare Industry News:  neuromodulation 

Devices Cardiology FDA

 News Release - February 5, 2009

St. Jude Medical Announces U.S. Approval of Industry's First Connector System Designed to Simplify Implant Process for Cardiac Resynchronization Therapy Devices

New lead and cardiac resynchronization system design is expected to offer implanting physicians a simpler and quicker procedure and reduces the volume of the leads and device in the chest pocket for heart failure patients

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) approval of the industry’s first medical device system that allows a single defibrillation lead connection between a cardiac resynchronization therapy defibrillator (CRT-D) and the wires (leads) that send electrical impulses to the heart to treat the symptoms of heart failure.

The new connector system, which includes the Durata® defibrillation lead with the SJ4 connector and the Promote® CRT-D with the SJ4 connector, is expected to make the overall procedure a simpler process. In addition, the new system reduces the volume of the leads and device in the chest pocket, which could lessen the risk of lead-to-can abrasion, a known complication.

The SJ4 connector system features a single connection between the CRT-D and the defibrillation lead and a single set screw. Current lead designs require three separate connections and four set screws. The St. Jude Medical SJ4 connector system was designed to meet the draft International Organization of Standardization (ISO) IS-4 standard but will not be labeled as such until the standard is published, which is expected later this year.

“By simplifying the lead connection process, the physician will be able to reduce procedure time for both initial implants and future device replacements,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “The SJ4 connector system also requires less lead and device volume in the body than previous designs, which could reduce the risk of lead abrasion as well as provide additional comfort to the patient.”

As a requirement of the FDA approval, St. Jude Medical will conduct a post-approval study that will enroll up to 1,700 patients and follow the group 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.

“We are pleased to be the industry leader in bringing this important new connector system to the U.S. market,” said Dr. Fain. “We look forward to working with the FDA to track the long-term benefits that we believe this technology will provide.”

St. Jude Medical will begin a limited release over the coming months and expects a full release of the product later this year. St. Jude Medical will continue to offer its other standard connector systems so that physicians can select a device configuration based on their preference and the individual needs of their patient.

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.

As with previously announced leads in the Durata lead family, the Durata lead with SJ4 connector features a soft silicone tip and Optim® insulation, a hybrid insulation material that provides increased durability, along with the flexibility and handling characteristics that facilitate device implantation.

The new Durata lead is the same diameter as the company’s current Durata high-voltage 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 or a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel.

The design of the Durata lead is based on the Riata® lead platform, which has been proven to have excellent performance and reliability. Recent studies–which analyzed the experience of 7,498 patients and more than 680 implanting physicians at more than 370 sites–found that performance and reliability of Riata leads are excellent, with very low adverse event rates for all categories of lead-related complications, including fracture, insulation abrasion, perforation and dislodgment.

The Promote CRT-D is an implantable cardiac resynchronization therapy defibrillator for the treatment of heart failure. Like its predecessor product, the Promote CRT-D with the SJ4 connector includes features designed to customize treatment to each patient’s unique needs. Built on the St. Jude Medical consolidated hardware and software “Unity” device platform, the Promote CRT-D includes the company’s advanced safety features and algorithms for better patient management. These include improved lead monitoring capabilities – including daily checks of all pacing and shock configurations – that provide added patient safety.

With this system, physicians are able to monitor changes in the patient’s heart and device therapy via remote transmissions from the St. Jude Medical Merlin@home™ transmitter (a remote monitoring system in patients' homes), and receive alerts through the Merlin.net™ Patient Care Network (PCN). The St. Jude Medical vibratory patient alert is the industry's only notifier that gently vibrates to notify patients of critical changes in device performance instead of issuing the standard audio alert; this can be especially beneficial for people with hearing loss.

Additional industry-leading features inside these devices include:
  • QuickOpt® timing cycle optimization - a programmer-based optimization method that is proprietary to St. Jude Medical that is used with CRT-Ds and ICDs to help physicians quickly program the device's timing cycles – in about 90 seconds - to help deliver optimal therapy to patients
  • DeFT Response® technology - which is designed to help devices meet the needs of patients with high or varying defibrillation thresholds, helping physicians to ensure appropriate delivery of life-saving therapy
  • SenseAbility® technology - which is designed to enable physicians to program the device to more accurately sense abnormal heart rhythms, thereby protecting the patient from receiving inappropriate shocks
Heart failure is a progressive dysfunction of the heart’s pumping action due to the heart’s inability to contract or relax properly. For the heart to work correctly, the main pumping chambers (the ventricles) must beat in a coordinated manner. In some heart failure patients, this coordination may be interrupted. The right and the left sides fail to beat in synchrony (together) and can actually work against each other.

Cardiac resynchronization therapy delivers electrical impulses to heart muscle in the two lower chambers, or ventricles. Called biventricular pacing, this causes both ventricles to contract at almost the same time, like in a normal heart. The goal of CRT is to synchronize the two ventricles (RV and LV) for optimal contraction, improving the efficiency of each contraction of the heart and the amount of blood pumped to the body. This therapy helps physicians lessen the symptoms of heart failure for their patients and, in many cases, helps to slow the progression of the disease.

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 five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology 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 Annual Report on Form 10-K for the fiscal year ended December 29, 2007 and Quarterly Report on Form 10-Q for the fiscal quarter ended September 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

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