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:

Related Content

FDA clears Claret Medical Sentinel embolic protection device for TAVR
Feature | Heart Valve Technology| June 09, 2017
June 5, 2017 – The U.S.
Contego Medical Receives CE Mark for Vanguard IEP Peripheral Balloon Angioplasty System
News | Peripheral Artery Disease (PAD)| May 17, 2017
Contego Medical LLC announced recently that it has received CE Marking of its Vanguard IEP Peripheral Balloon...
PinnacleHealth Initiates Clinical Study of TriGuard Embolic Protection Device
News | Embolic Protection Devices| April 11, 2017
Through a new clinical trial, patients at Harrisburg, Pa.-based PinnacleHealth have access to an investigational device...
Cardiogard embolic protection system for surgical valve reaplacement

The CardioGard embolic protection system for surgical aortic valve replacement.

Feature | Embolic Protection Devices| March 22, 2017
March 22, 2017 — Two U.S.
InspireMD, CGuard embolic protection system, EPS, clinical data, internal carotid artery stenosis, ICA
News | Stents Carotid| November 18, 2016
November 18, 2016 — InspireMD Inc.
Sponsored Content | Videos | Heart Valve Technology| November 08, 2016
Studies have shown transcatheter aortic valve replacement (TAVR) has an increased risk of stroke and cerebral damage
TAVR, post-procedure, brain lesions, delirium, TCT 2016, Peter R. Stella
News | Heart Valve Technology| November 07, 2016
Keystone Heart Ltd. announced that data presented at the Transcatheter Cardiovascular Therapeutics (TCT) 2016...
Sentinel, TAVR, TAVI, embloic protection
News | Heart Valve Technology| November 07, 2016
November 7, 2016 – A multicenter randomized trial evaluating the role of embolic protection using the Sentinel device
Keystone Heart, TriGuard Embolic Protection Device, real-world results, PCR London Valves Conference 2016
News | Embolic Protection Devices| September 29, 2016
Keystone Heart Ltd. recently announced the safety and efficacy of the TriGuard Cerebral Embolic Protection device...
Overlay Init