Medtronic, Philips Enroll Patients In Respective Cardiovascular Device Trials
By Jof Enriquez,
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Medtronic and Philips enrolled patients into separate clinical trials for their respective cardiovascular devices. Medtronic’s study is an expanded indication trial for its CoreValve Evolut R System transcatheter aortic valve replacement (TAVR) device, while Philips is testing its proprietary instant wave-Free Ratio (iFR) blood pressure measurement technology for blocked coronary arteries.
In June 2015, Medtronic received FDA approval for the CoreValve Evolut R System – the first recapturable and repositionable TAVR system offered in the United States – for patients suffering from severe aortic stenosis and at high or extreme risk for surgery. The new clinical trial for the expanded indication of the TAVR device will include 1,200 patients with severe aortic stenosis who have a less than 3 percent risk of operative mortality, as well as low-risk patients from up to 80 clinical sites, with 1:1 randomization to receive the Evolut R System or undergo open-heart surgery (surgical aortic valve replacement or SAVR). In addition, the trial includes a sub-study of leaflet mobility in 400 patients.
"Our team of cardiologists and cardiovascular surgeons is pleased to be involved in this next phase of clinical investigation," said Mubashir Mumtaz, M.D., F.A.C.S., F.A.C.C. chief of cardiothoracic surgery at PinnacleHealth CardioVascular Institute, Harrisburg, PA, in a press release. "It is invigorating to be on the national forefront of care and to help heart teams understand the potential benefits of TAVR in a broader patient population."
The Evolut R System builds on knowledge gained in the development of CoreValve, an earlier-approved TAVR device offering multiple sizes of self-expanding valves that are the smallest available on the market and ideal for patients with exceptionally small vasculature. The Evolut R System features a new design that allows it to be recaptured and repositioned during the implantation procedure, thereby increasing conformability and sealing at the annulus, while maintaining supra-annular valve positioning for improved blood flow and hemodynamic performance, according to Medtronic.
While Medtronic's clinical trial seeks to strengthen its competitive edge in the TAVR market, Philips' trio of studies concentrate on a pioneering technology for the image-guided therapy (of the heart and blood vessels) market, in which Philips is considered a leader.
Philips acquired catheter-based imaging company Volcano Corporation, for $1.2 billion in 2014, to make inroads into this segment. Up until the acquisition, Volcano was the only company in the industry with a leading position in both intravascular ultrasound (IVUS) imaging catheters capable of producing ultrasound images of blood vessels’ interiors, and fractional flow reserve (FFR) catheters that are used to assess the blood flow, stated Philips. These products complemented Philips’ portfolio of interventional X-ray and ultrasound imaging equipment, navigation systems, and related software and services.
The three clinical trials, involving more than 5,000 patients (including 2,000 with acute coronary syndrome), will compare the safety of Philips Volcano’s proprietary iFR pressure measurement technology versus conventional FFR measurements. Both types of measurement are performed with the aid of a guide wire-based pressure sensor, inserted into a blocked coronary artery via a small incision in the patient’s leg. The measurements determine whether the blockage is significant enough to cause a shortage of oxygen to the heart muscle (myocardial ischemia).
FFR used in conjunction with interventional X-ray is clinically proven to improve procedure outcomes and reduce healthcare costs. However, FFR requires the injection of a hyperemic agent to dilate the artery, whereas iFR’s ability to synchronize pressure measurements to a ‘wave-free’ period in the patient’s heartbeat means that no hyperemic agent is needed, reducing costs and complexity, according to Philips.
“We are all really excited about completing enrollment for the DEFINE-FLAIR, iFR SWEDEHEART and SYNTAX II studies,” said Professor Patrick W.J.C. Serruys, DEFINE-FLAIR study chairman and SYNTAX II steering committee chairman, Erasmus MC, Rotterdam, the Netherlands, in a statement. “Together, these three major clinical outcome studies will more than double the randomized published physiology data, and have the potential to re-shape revascularization guidelines and help physicians perform PCI procedures more likely to benefit their patients.”