News | July 25, 2007

FDA Gives Green Light to St. Jude’s Embolic Protection System, Flow Control Device

July 26, 2007 - St. Jude Medical Inc. announced that the FDA has granted clearance for the 7F Proxis Embolic Protection System, a system designed 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 provides protection proximally, or "upstream," from an SVG blockage. As stenting may dislodge debris that flows downstream, thus increasing the risk of heart attack, stroke or other complications, the embolic protection system is engineered to extract dislodged debris. Additionally, the Proxis Embolic Protection System allows cardiologists to remove dislodged debris floating in the bloodstream.
The 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 before delivering the interventional device to the diseased area. Once the intervention is complete, fluid and debris are aspirated from the vessel.
In a related story, the FDA cleared St. Jude Medical for its 6F Proxis Flow Control System, a smaller device for controlling the flow of fluids in the coronary and peripheral vasculature by temporarily suspending blood flow within a vessel. This technique assists clinicians in visualizing the lesion or delivering other therapies.

For more information: www.sjm.com

Related Content

Boston Scientific Closes Claret Medical Acquisition, Announces Positive Reimbursement Decision
News | Embolic Protection Devices | August 03, 2018
Boston Scientific Corp. announced it has recently closed its acquisition of Claret Medical Inc., a privately-held...
Claret's FDA-cleared Sentinel Cerebral Embolic Protection System for TAVR will expand Boston Scientific's structural heart portfolio. It collects emboli knocked loose that would otherwise lodge in the brain and potentially cause a stroke.

Claret's FDA-cleared Sentinel Cerebral Embolic Protection System for TAVR will expand Boston Scientific's structural heart portfolio. It collects emboli knocked loose that would otherwise lodge in the brain and potentially cause a stroke. 

News | Embolic Protection Devices | July 20, 2018
July 20, 2018 — Boston Scientific Corp.
The Emboliner Embolic Protection Catheteris designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures.

The Emboliner Embolic Protection Catheter is designed to capture debris released from the valve and vessel walls during transcatheter aortic valve replacement (TAVR) procedures. It allows for the passage of other catheters during TAVR procedures. 

News | Embolic Protection Devices | June 07, 2018
June 7, 2018 — The first clinical cases have been completed where the Emboliner...
Sentinel Cerebral Protection System Reduces TAVR Strokes More Than 60 Percent
News | Embolic Protection Devices | May 08, 2018
May 8, 2018 — One-year results from the Sentinel Cerebral Protection System show it can reduce the incidence of...
Emboline Inc. Completes Funding for TAVR Embolic Protection Trial
News | Embolic Protection Devices | April 20, 2018
Emerging medical device company Emboline Inc. announced it has completed a Series B funding round totaling over $10...
Sentinel Cerebral Protection System Reaches 50-Center Adoption Milestone in U.S.
News | Embolic Protection Devices | February 19, 2018
Claret Medical announced that since U.S. Food and Drug Administration (FDA) clearance in June 2017, its Sentinel...
The Boston Scientific FilterWire EZ embolic protec filter system.

The Boston Scientific FilterWire EZ embolic protection system.

News | Embolic Protection Devices | October 31, 2017
October 31, 2017 — The VAMPIRE 3 study evaluated if the selective use of distal filter protection might decrease the
Claret Medical Closes $14.5 Million in Series C Financing for Sentinel Cerebral Protection System
News | Embolic Protection Devices | October 23, 2017
October 23, 2017 — Claret Medical announced that it has closed on a Series C financing of $14.5 million led by Lights
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices | September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Protembis Announces Successful First-in-Human Use of  ProtEmbo Cerebral Protection System in European Trial
News | Embolic Protection Devices | September 07, 2017
Protembis GmbH announced the first clinical applications of its ProtEmbo Cerebral Protection System to complement a...
Overlay Init