Healthcare Industry News:  Cardiac Resynchronization Therapy 

Devices Cardiology FDA Regulatory

 News Release - May 15, 2008

St. Jude Medical Announces FDA Clearance and European CE Mark Approval for Tools That Help Place Leads in Challenging Heart Anatomy

Delivery tools designed to provide access to optimal, but difficult-to-reach, positions

ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc. (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance and European CE Mark approval of new delivery tools designed to give physicians greater control and precision when placing cardiac pacing leads in challenging heart anatomy. The CPS Duo™ stylet and guidewire system and the CPS Courier™ guidewire received FDA clearance and CE Mark approvals, and the Mond™ stylet received FDA clearance. The tools are designed to place leads in precise positions that, while optimal for delivering pacing therapy, can be difficult to access.

“The CPS Duo system provides a new level of control for delivering the QuickFlex and QuickSite leads to often challenging locations in the heart,” said John Rogers, M.D., from Scripps Clinic in La Jolla, Calif. “This means that I can more easily maneuver the lead to the best position for the patient.”

The CPS Courier guidewire and the CPS Duo system are part of the St. Jude Medical portfolio of heart failure lead delivery tools (used when implanting Cardiac Resynchronization Therapy, or CRT, systems) that help physicians navigate the left side of the heart. The left side of the heart is usually the most challenging to access but is critical in treating patients suffering the debilitating effects of heart failure. When both a stylet and guidewire are used during an implant procedure, physicians often switch between the two products. The CPS Duo system gives physicians a two-in-one tool that is designed to reduce exchanges between the stylet and guidewire, thereby simplifying complex procedures and potentially saving valuable clinic time.

“Physicians should have as many options available to them as possible as they determine how best to care for their patients,” said Eric S. Fain, M.D., president of the St. Jude Medical Cardiac Rhythm Management Division. “With these new products, we are putting tools into our physicians’ hands that give them more control by enabling them to get the lead to a targeted location in the heart more efficiently, with as few limitations as possible, so that patients are able to receive the best pacing therapy for their individual conditions.”

The CPS Duo System

The CPS Duo system is a combination of a hollow stylet and compatible guidewire. Stylets provide support and straighten the lead tip during implantation. Guidewires are used to access the desired location in the heart, and then function as a track over which the lead is advanced into the heart.

The CPS Duo system guidewires provide flexibility and support, while the stylet provides stiffness needed to advance the lead and manipulate its tip. Together, the products provide greater maneuverability and control of the left-ventricular lead than either tool could supply alone. The system also features a radiopaque tip for visibility under fluoroscopy and a marker that indicates when the lead tip is bent 90 degrees, which aids in maneuverability.

The CPS Courier Guidewire

The CPS Courier guidewire also is designed specifically to overcome the challenges of delivering a lead to the heart’s left side. This guidewire features a kink-resistant core wire with a smooth transition toward the tapered end, which provides support for the lead. The guidewire also features a platinum coil for visualization under fluoroscopy, a shaping ribbon so it can be formed according to specific needs, and a polymer jacket, which provides a smooth surface for improved movement through both leads and heart vessels.

The CPS Duo system and the CPS Courier guidewire are designed to be used with the St. Jude Medical QuickFlex® and QuickSite® leads (both of which are used for heart failure patients).

The Mond Stylet

The Mond stylet also is designed to aid the placement of leads to an alternate site within the lower chambers of the heart, specifically the right ventricular outflow tract (RVOT). Therapy delivered from the RVOT more closely replicates the normal function of the heart, compared to pacing in the lower portion of the right chamber (the apex), and recent publications have reported that pacing from the apex may have deleterious effects to the patient.

The Mond stylet is pre-shaped and features a three-dimensional curve designed to assist in the placement of pacing and defibrillation leads in the RVOT. To provide physicians with more control and options to steer the lead through the heart’s anatomy to the desired targeted lead position, the Mond stylet is available in different curves, configurations, degrees of stiffness and lengths. It is designed to enable physicians to find the target position, and smoothly place the lead and remove the stylet.

About Heart Rhythm 2008

The CPS Duo system, CPS Courier guidewire and Mond stylet will be featured at Heart Rhythm 2008, which takes place May 14-17 at the Moscone Convention Center in San Francisco. The meeting is the most comprehensive educational event on heart rhythm disorders, offering 250 educational opportunities in multiple formats. The world’s most renowned scientists and physicians will present a wide range of heart rhythm topics including advances in statins, Cardiac Resynchronization Therapy, catheter ablation, cardiac pacing and heart failure and the latest technology, including state-of-the-art pacemakers and defibrillators.

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 12,000 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

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 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.

Source: St. Jude Medical

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