Feature | June 14, 2013

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

European interventional cardiology market, drug-eluting stents, Abbott Laboratories, Boston Scientific, Medtronic

Boston Scientific's Eluvia drug-eluting vascular stent system. Image courtesy of Boston Scientific.

Feature | Stents| July 31, 2015
According to a new report on the Europe market for interventional cardiology by iData Research, drug-eluting stents...
Navidea, Mass General, Tc99m-tilmanocept, vulnerable plaque, cardiovascular disease, Harvard
News | Radiopharmaceuticals and Tracers| July 30, 2015
Navidea Biopharmaceuticals Inc. announced plans to move forward with a joint study of the ability of Tc99m-tilmanocept...
Hansen Medical, Magellan 10 French Robotic Catheter, FDA 510(k) clearance
Technology | Robotic Systems| July 29, 2015
The Magellan 10 French Robotic Catheter from Hansen Medical is indicated for use in the peripheral vasculature.
MSCs, stem cells, end-stageheart failure, retrograde, coronary sinus,
News | Stem Cell Therapies| July 29, 2015
A new clinical trial to test how a high dose of stem cells delivered via a method called retrograde coronary sinus...
Products | Guidewires| July 28, 2015
The Safari2 Pre-Shaped Guidewire.
CSI, ViperWire Advance Peripheral Guide Wire with Flex Tip, Stealth, Diamondback

Diamondback 360 Peripheral OAS image courtesy of Cardiovascular Systems Inc.

Technology | Atherectomy Devices| July 22, 2015
Cardiovascular Systems Inc. announced that it has received U.S. Food and Drug Administration (FDA) clearance for its...
heart failure, Adaptive CRT trial, AdaptivCRT algorithm, readmissions
News | Heart Failure| July 22, 2015
Heart failure patients had a significantly lower chance of being readmitted within 30 days of discharge when treated...
Direct Flow Medical, Transcatheter Aortic Valve System, SALUS Trial, FDA
News | Heart Valve Repair| July 22, 2015
Direct Flow Medical Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug...
The Medicines Company, bivalirudin, Angiomax, litigation, Hospira Inc.
News | Cath Lab| July 22, 2015
The Medicines Company announced the U.S. Court of Appeals for the Federal Circuit Court has ruled against the company...
Overlay Init