Healthcare Industry News: TCT
News Release - July 25, 2007
St. Jude Medical Announces FDA Clearance of the Proxis Embolic Protection SystemProxis is Industry's First "Upstream" Embolic Protection System
ST. PAUL, Minn.--(HSMN NewsFeed)--St. Jude Medical, Inc., (NYSE:STJ ) today announced U.S. Food and Drug Administration (FDA) clearance of the 7F Proxis(TM) Embolic Protection System.
The Proxis Embolic Protection System is intended to extract debris that may become dislodged when an intervention, such as delivering a stent, is performed on patients who have previously undergone a heart bypass procedure using a saphenous vein graft (SVG). The Proxis Embolic Protection System is the first FDA cleared embolic protection system to provide protection proximally, or "upstream," from an SVG blockage.
Approximately 240,000 SVG interventions are performed worldwide each year, where patients with coronary blockages undergo bypass surgery in which a portion of the saphenous vein from the leg is sutured to the aorta, and to a coronary artery, to create a "bypass," or new passage for blood flow. If the SVG itself develops a blockage, interventional cardiologists often perform an interventional procedure, such as delivering a stent, to open the blocked SVG. However, stenting may dislodge debris that can flow downstream, or embolize, thereby increasing the risk of heart attack, stroke or other complications. Embolic protection systems are used to extract such dislodged debris.
"Embolic protection has become an important part of caring for my patients. With proximal protection with the Proxis device, I am able to treat a wider range of patients that I was unable to treat previously," said Daniel Dadourian, M.D., Hahnemann University Hospital, Philadelphia, Penn., the first physician to use the Proxis System post-FDA clearance. "Proxis is a welcome addition to my interventional procedures. It is intuitive to use and offers some dramatic advantages over traditional embolic protection technology."
The Proxis Embolic Protection System allows cardiologists to remove dislodged debris floating in the bloodstream. This is an advantage over other embolic protection devices which can allow small particles to pass through a filter mesh or slip around the filter entirely. Conventional filters can also be overwhelmed by large amounts of debris, causing them to clog or overflow.
The Proxis Embolic Protection System includes an inflation device and a catheter with a vessel-sealing balloon. Cardiologists inflate the sealing balloon upstream to the lesion and temporarily suspend blood flow. With bloodflow suspended, the cardiologist delivers the interventional device to the diseased area. Once the intervention is complete, fluid and debris are aspirated, or removed from the vessel. The Proxis balloon is then deflated, restoring blood flow, and Proxis is removed from the SVG.
The clinical data from the PROXIMAL Trial, presented at TCT 2005 (Transcatheter Cardiovascular Therapeutics), demonstrated the Proxis Embolic Protection System to be as effective as other systems previously cleared by the FDA. Trial data also showed lower rates of major adverse cardiac events with the Proxis Embolic Protection System than with distal ("downstream") embolic protection devices.
St. Jude Medical previously obtained European CE Mark approval and Canadian approval of the Proxis Embolic Protection System.
St. Jude Medical also received FDA clearance for its 6F Proxis Flow Control System, a slightly smaller device that is intended to control the flow of fluids in the coronary and peripheral vasculature by temporarily suspending blood flow within a vessel. The suspended column of fluid can be used to aid visualization of the lesion or be used as a means of local and temporary delivery of other therapies. The safety and efficacy of the 6F Proxis Flow Control System as an embolic protection system has not been established.
About St. Jude Medical
St. Jude Medical is dedicated to making life better for cardiac, neurological and chronic pain patients worldwide through excellence in medical device technology and services. The Company has five major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiac surgery, cardiology and neuromodulation. Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 12,000 people worldwide. For more information, please visit www.sjm.com.
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 Company's Annual Report on Form 10-K filed on February 28, 2007 (see pages 13-20) and Quarterly Report on Form 10-Q filed on May 9, 2007 (see pages 23-24). 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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