A recent landmark study in the peer-reviewed journal Circulation further verifies the efficacy of Medtronic, Inc.'s, GuardWire Plus Temporary Occlusion and Aspiration System.
The Circulation article chronicles results from the Safer trial, the largest ever randomized study of balloon-based distal protection technology in patients with diseased saphenous vein grafts. Results demonstrated a 42 percent relative reduction in major adverse clinical events (MACE) after using the GuardWire Plus system. The first-of-its-kind system, which has been available in the U.S. since last year, protects against potentially catastrophic events in patients undergoing diseased saphenous vein graft stenting.
"This publication furthers one of the most promising new chapters in the practice of interventional cardiology in the world today," said Bill Hawkins, president, Medtronic Vascular. "We fully expect that the publication of this peer-reviewed study will further drive acceptance of distal protection and the GuardWire Plus system as the standard of care for patients undergoing diseased saphenous vein graft interventions."
Donald Baim, M.D., Brigham and Women's Hospital, Boston, Mass., and principal investigator for the Safer study published in the March 19, 2002 issue of Circulation noted that "the SAFER study makes clear the importance of preventing distal atheroembolization and the benefit of devices that prevent it during catheter-based interventions in diseased saphenous vein grafts."
The GuardWire Plus System is the first distal protection system available in the United States and is indicated for use in diseased saphenous vein graft interventions. Distal protection systems were developed as a result of the growing awareness that atherosclerotic debris frequently loosens during angioplasty or placement of stents in diseased saphenous vein grafts. Studies have shown that if this debris is not captured and withdrawn, it can migrate downstream and may result in clinical complications, such as a heart attack.
The Saphenous Vein Graft Angioplasty Free of Emboli Randomized (Safer) study was a 801-patient, U.S.-based multicenter study in which patients undergoing saphenous vein graft intervention were randomized to either stenting with a conventional guidewire or stenting with the GuardWire Plus distal protection device. The final endpoint of the study, MACE rate at 30 days, was defined as the composite of death, myocardial infarction, emergent bypass surgery or target vessel vascularization. Results were reviewed by an independent Data and Safety Monitoring Committee, which recommended early termination of the trial on the basis of finding a significant benefit for patients in the treatment arm of the study.
"The Safer trial demonstrated conclusively that distal protection with the GuardWire Plus during diseased saphenous vein graft intervention reduces by nearly half the incidence of major adverse cardiac events," said Dr. Baim. "These study results reinforce the significance of distal embolization as a cause of adverse events and signal that distal protection should be considered the standard of care when treating these grafts - and potentially in other areas within the vasculature where distal embolization causes significant end-organ damage."
The GuardWire Plus system is used by clinicians at the start of an interventional procedure, replacing the conventional angioplasty guidewire. The system, which contains a balloon at its distal tip, is deployed across the lesion and inflated to occlude the vessel and prevent migration of embolic particles that may become dislodged during an intervention. The angioplasty balloon and/or stent systems are then advanced over the GuardWire Plus system to the treatment site, where the dislodged particles remain suspended in the occluded vessel. Upon completion of the interventional procedure, the Export(r) Aspiration Catheter is introduced, and the atherosclerotic particles are aspirated. The GuardWire Plus balloon is then deflated and removed.
Medtronic pioneered distal protection systems and is currently evaluating the use of the GuardWire Plus distal protection system, as well as filter systems, in carotid artery and other vascular interventions. The GuardWire Plus system joins the full suite of Medtronic Vascular solutions for the treatment of coronary artery disease, including the S660 Coronary Stent Systems (for small vessels), the S7 Coronary Stent Systems, the BeStent 2 Coronary Stent Systems, the D1 and D2 balloons, and the Zuma and Z2 guide catheters, all components of a complete therapeutic system for treating cardiovascular disease. Other products include steerable guidewires, diagnostic catheters and accessories for angioplasty procedures.