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

Medtronic, CoreValve Evolut R, TAVR system, 34 mm valve, FDA approval, largest in the U.S.
Technology | Heart Valve Technology| October 26, 2016
Medtronic plc announced the U.S. Food and Drug Administration (FDA) approval and U.S. launch of the CoreValve Evolut R...
UAB, University of Alabama at Birmingham study, stroke prevention, non-valvular atrial fibrillation, NVAF
News | Atrial Fibrillation| October 25, 2016
A recent study from University of Alabama at Birmingham (UAB) researchers published in PLOS ONE compares different...
pediatric echocardiograms, cardiovascular ultrasound, therapy dog impact, animal-assisted therapy, Human Animal Bond Research Initiative, HABRI
News | Cardiovascular Ultrasound| October 25, 2016
The Human Animal Bond Research Initiative (HABRI) announced it has awarded a $44,000 grant to Duke University School of...
medicare bundled cardiac payments, CMS cardiology payments
Feature | Business| October 24, 2016 | By John W. Meyer, MPH, FACHE
(Editor’s note: This is the second part of a two-part series on the proposed Medicare five-year demonstration for
bioresorbable stents, bioabsorbable stents, visualizing the Absorb BVS, dissolving stent, disappearing stent on IVUS and OCT

A comparison of how the Abbott Absorb BVS appears with intravascular ultrasound (IVUS) on the left, and optical coherence tomography (OCT) of the right. The stent is difficult to visualize and sizing is critical, so both modalities can help in bioresorbable stent measurements and to confirm stent apposition. Left image from the Volcano IVUS system and the right image from St. Jude Medical's OCT system


Feature | Stents Bioresorbable| October 20, 2016 | Dave Fornell
There has been a lot of interest in the interventional community regarding the Abbott Absorb Bioresorbable Vascular S
Avinger, Pantheris atherectomy catheter, OCT, Lumivascular technology, expanded FDA indication, diagnostic imaging device
News | Atherectomy Devices| October 20, 2016
Avinger Inc. recently announced that the company has received expanded indications from the U.S. Food and Drug...
St. Jude Medical, ADO II AS trial, congenital heart disease, PDA, Amplatzer Duct Occluder II AS
News | Congenital Heart| October 19, 2016
St. Jude Medical Inc. announced the launch of the ADO II AS (AMPLATZER Duct Occluder II Additional Sizes) pediatric...
recall, alligator retrieval device, X-Celerator hydrophilic guidewire, UltraFlow flow directed micro catheters, Marathon flow directed micro catheters
News | Cath Lab| October 18, 2016
Medtronic plc announced last week that it has notified customers of a voluntary recall of certain lots of its Pipeline...
Inventory management, Cardinal, RFID inventory tracking, cath lab inventory
Sponsored Content | Whitepapers | Inventory Management| October 18, 2016
As healthcare moves into the era of bundled payments, providers need to be especially focused on ensuring delivery of
Overlay Init