Healthcare Industry News:  vascular access 

Devices Interventional FDA Regulatory

 News Release - March 11, 2010

New Introducer Product Line from St. Jude Medical Offers Reliable Access and Facilitates Arterial Closure

Engage Family offers physicians state-of-the-art introducers capable of facilitating both femoral and radial access

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 for the Engage™ and Engage TR™ Introducers. Introducers are the starting point of cardiac catheterization for diagnostic and interventional procedures, helping physicians to safely gain and maintain vascular access.

The new Engage Family of Introducers™, uniquely designed to provide physicians with reliable access, enhance the company’s rich portfolio of introducers which have been trusted by physicians for nearly 20 years. Drawing upon its experience in both access and closure, St. Jude Medical designed the Engage Family of Introducers with features intended to minimize trauma to the artery and set the stage for closure using Angio-Seal™ or other closure devices.

The Engage Family of Introducers was designed to create a smooth and reliable means of accessing vasculature for a wide variety of patients and procedures. The Engage Introducer is used for femoral access, in which physicians access the patient’s heart through the femoral vein or artery located near the groin; this portfolio includes 22 model configurations of varying sizes to accommodate a wide variety of procedures. The Engage TR Introducer portfolio includes 18 model configurations and expands the company’s product offering to include introducers used to facilitate transradial (TR) procedures, in which physicians access the patient’s heart through the radial artery in the arm.

“The new Engage Family of Introducers help to set the stage for a successful procedure by reducing the number of potential variables that can affect patient outcome,” said Dr. Javier Goicolea from Hospital Puerta de Hierro in Majadahonda, Spain. “While some introducers were designed to just perform the basic access function, the Engage Introducers were designed with the entire procedure in mind, including a successful closure.”

Though uncommon, some risks reported by physicians during interventional and diagnostic procedures include bleeding, vessel trauma, vasospasm (a condition that causes the vessel to constrict), or formation of blood clots within the introducer. The Engage Family of Introducers incorporates new features that were designed to offer physicians more control and minimize these risks both during access and throughout the procedure.

“St. Jude Medical is focused on developing products that reduce risk and improve physician control during procedures,” said Frank Callaghan, president of St. Jude Medical’s Cardiovascular Division. “The Engage Introducers were designed to provide physicians with reliable femoral and radial vascular access that can be easily repeated for any patient, no matter their individual anatomy or medical history.”

The Engage Family of Introducers will be on display during the American College of Cardiology (ACC) Conference at the Georgia World Congress Center in St. Jude Medical booth 718 on Sunday, March 14, 9 a.m. - 4:30 p.m., Monday, March 15, 9 a.m. - 4:30 p.m. and Tuesday, March 16, 9 a.m. - 1 p.m. The products will additionally be on display at the Society of Interventional Radiology (SIR) Annual Meeting at the Tampa Convention Center on Sunday, March 14 to Tuesday, March 16 from 9:30 a.m. to 4:30 p.m. and on Wednesday, March 17 from 9:30 a.m. to 2 p.m.

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 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

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 January 2, 2010. 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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