Feature | June 14, 2013

Volcano Shares Results for Its iFR Technology From ADVISE II Study

Prospective, multi-center, double-blinded study confirms prior results in evaluating Volcano’s iFR (Instant Wave-Free Ratio) software modality in a large, real-world population

June 14, 2013 — Preliminary results from the ADVISE (Adenosine Vasodilator Independent Stenosis Evaluation) II trial confirm prior retrospective publications and demonstrate the clinical usefulness of an iFR/fractional flow reserve (FFR) hybrid approach to simplify lesion assessment and to save the use of hyperemic drugs in a significant number of patients. It was also announced that this hybrid iFR/FFR strategy, along with intravascular ultrasound (IVUS) guidance, will be used in the multi-center SYNTAX2 trial in Europe starting later this year.

The ADVISE II findings replicated prior iFR retrospective publications, which demonstrated that use of a hybrid iFR/FFR workflow delivered an overall classification agreement with an FFR in more than 90 percent of patients participating in the trial, while saving more than 50 percent of such patients from hyperemic drug administration. In fact, the preliminary analysis showed 91.5 percent agreement with FFR and 71.5 percent hyperemic drug savings on a per lesion basis. Patients in ADVISE II were recruited from more than 40 centers in the United States and Europe, and all analysis was performed with operators blinded from the iFR values which were calculated offline at an independent core lab in Rotterdam, Netherlands.

Results from the first 392 real-time cases performed live in the cath lab from more than 20 centers in Europe, Japan and South Africa that are now equipped with the iFR software confirmed the prior results and those of the preliminary ADVISE II findings.

“After using iFR in real world clinical practice, it’s simplicity is clearly its strength. In a busy cath lab, saving time is important and the results in my early experience have been consistent and clinically useful,” commented Andrew Sharp, M.D., interventional cardiologist at Royal Devon and Exeter Hospital, Exeter, United Kingdom. “Once real-world operators have the opportunity to use both of these complementary technologies, I think they will be impressed.”

Volcano and Boston Scientific Corp. will also co-sponsor the investigator-led SYNTAX2 clinical study. SYNTAX2 is designed to test precision guided percutaneous coronary intervention (PCI), using a clinical SYNTAX score as derived at Cardialysis in Rotterdam along with live iFR/FFR hybrid measurements of the vessel to determine which patients and lesions are treated. Boston Scientific Synergy drug-eluting stents will then be placed with IVUS guidance, using both Volcano and Boston Scientific IVUS devices, to provide more accurate stent placement than has been demonstrated with angiography alone. 

For more information: www.volcanocorp.com

Related Content

cardiac surgery, simulation training, University of Washington, case studies

Multiple repetitions of bypass grafts on a heart, using the Ramphal simulator. Courtesy of the University of Washington in Seattle.

News | Cardiovascular Surgery| August 25, 2016
August 25, 2016 — Simulation training fo
aortic dissection, family history, same age, clinical study, John A. Elefteriades, Annals of Thoracic Surgery
News | Structural Heart| August 25, 2016
People with a family member who had an aortic dissection — a spontaneous tear in one of the body’s main arteries —...
nanoparticles, blood clotting, internal bleeding, American Chemical Society study, Erin B. Lavik

Nanoparticles (green) help form clots in an injured liver. The researchers added color to the scanning electron microscopy image after it was taken. Image courtesy of Erin Lavik, Ph.D.

News | Hemostasis Management| August 24, 2016
August 24, 2016 — Whether severe trauma occurs on the battlefield or the highway, saving lives often comes down to...
Intact Vascular, TOBA clinical study, one-year results, Tack Endovascular System, Journal of Vascular Surgery
News | Peripheral Arterial Disease (PAD)| August 24, 2016
Intact Vascular Inc. announced that the one-year results from its Tack Optimized Balloon Angioplasty (TOBA) clinical...
Technavio report, renal denervation devices, 2015
News | Renal Denervation| August 23, 2016
August 23, 2016 — Technavio analysts forecast the global...
News | Heart Failure| August 23, 2016
August 23, 2016 — A new study of more than 13,000 people has found that so-called morbid obesity appears to stand alo
Jason Burdick, injectable hydrogels, heart failure, heart attack, American Chemical Society

Compared to other types of hydrogels being developed (left), a new hydrogel (right) can form crosslinks after injection into the heart, making the material stiffer and longer-lasting. Image courtesy of American Chemical Society.

News | Heart Failure| August 23, 2016
August 23, 2016 — During a heart attack, clots or narrowed arteries block blood flow, harming or killing cells within
News | Peripheral Arterial Disease (PAD)| August 22, 2016
Avinger Inc. recently announced the closing of its previously announced public offering of 9,857,800 shares of Avinger’...
sleep apnea, hypertension, clinical study, Science Signaling, University of Chicago
News | Hypertension| August 22, 2016
Obstructive sleep apnea is a common cause of high blood pressure. In the Aug. 17, 2016, issue of the journal Science...
DMC Heart Hospital, Detroit Medical Center, complex percutaneous intervention education course, PCI, cath lab training
News | Cath Lab| August 22, 2016
The Detroit Medical Center (DMC) Heart Hospital recently completed a Complex Percutaneous Intervention education course...
Overlay Init