Healthcare Industry News:  AMPLATZER 

Devices Interventional FDA

 News Release - June 18, 2012

St. Jude Medical Announces FDA Clearance of the AMPLATZER Vascular Plug 4

Device allows physicians to reroute blood flow by blocking abnormal vessels

ST. PAUL, Minn.--(Healthcare Sales & Marketing Network)--St. Jude Medical, Inc. (STJ), a global medical device company, today announced it has received U.S. Food and Drug Administration (FDA) clearance and will immediately launch the AMPLATZER™ Vascular Plug 4 (AVP 4) for use in transcatheter embolization procedures (minimally invasive procedures that involve the selective blocking of blood vessels) within the peripheral vasculature. Approximately 50,000 peripheral embolizations are performed each year in the United States.

As the industry’s first vascular plug that can be delivered using a standard diagnostic catheter, the AVP 4 offers physicians the ability to treat smaller and more difficult-to-access blood vessels using vascular plug technology. The AVP 4 also provides full cross-sectional vessel coverage and may be recaptured and repositioned prior to deployment, allowing physicians to block a vessel with greater precision and speed than is achievable with conventional embolic coils.

“The AMPLATZER Vascular Plugs have been beneficial in precisely targeting specific vessels for embolization,” said Dr. Jafar Golzarian of the University of Minnesota Medical Center in Minneapolis. “With the AMPLATZER Vascular Plug 4 we now have the ability to use a diagnostic catheter to deliver the device, which means that patients in need of embolization of smaller, more tortuous vessels can benefit from this technology.”

Vascular plugs assist physicians in quickly blocking or rerouting blood flow by occluding (closing) abnormal blood vessels. Vascular occlusion lessens pressure on malformed, weakened or leaking blood vessels and reduces blood supply to benign or malignant tumors. The current standard of care for vascular occlusion involves placing several individually threaded coils through a catheter and packing them together to block blood flow.

“Approval of the AVP 4 represents a significant milestone for our U.S. vascular business,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular Division. “This technology simplifies the peripheral embolization procedure for physicians by eliminating the need for catheter exchanges and blocking or redirecting blood flow through the peripheral vessels in a more efficient manner than with surgical clips or embolic coils. We are excited to offer the U.S. market a more complete family of vascular plugs for peripheral embolization.”

The AMPLATZER Vascular Plug 4 received European CE Mark approval in July 2009.

About the AMPLATZER Family of Vascular Plugs

AVP 4 is the latest addition to the AMPLATZER Family of Vascular Plugs, which includes the AVP and AVP II devices in the U.S. The AMPLATZER Family of Vascular Plugs are designed to provide optimal embolization of peripheral arteries and veins through single-device occlusion; full cross-sectional vessel coverage; and controlled, precise deployment. A single device from the AMPLATZER Family of Vascular Plug embolizes a vessel that would often require many coils, which makes it an efficient and cost-effective alternative.

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. St. Jude Medical is headquartered in St. Paul, Minn. 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 December 31, 2011 and Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012. 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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