St. Jude Medical's ($STJ) data dump at the European Society of Cardiology Congress in Barcelona, Spain, was heartening news for the company's products--especially those used to measure a ratio known as fractional flow reserve.
Results from the FAMOUS-NSTEMI clinical trial of 350 heart attack patients showed that St. Jude's PressureWire for measuring fractional flow reserve resulted in a changed treatment strategy of about one-fifth of the patients, the company said. The study also found that fractional flow reserve technology results in fewer procedure-related heart attacks than when the surgery is performed using solely angiography (an X-ray of the blood vessels in the heart).
The PressureWire guidewire is used to deliver interventional tools to the heart by navigating various vessels to arrive at the target destination. It also contains sensor chip technology for making measurements of various parameters, according to the product website.
FFR measurement is a method of determining the ratio of the maximum blood flow in a healthy coronary artery to that achievable in a diseased counterpart. It is "defined as the ratio of maximal blood flow in a stenotic (narrowed) artery to normal maximal flow, expressed as a fraction of the normal blood flow in an artery compared to the maximum achievable blood flow in the same artery," St. Jude explains on its website. An FFR ratio below .75 is worrying and means blood flow blockage caused by the narrowing of the artery is responsible for inadequate blood supply.
"Using St. Jude Medical PressureWire, physicians can leverage FFR to better assess the need for interventional procedures and more accurately identify lesions that require stenting,"
In another FFR-related development, St. Jude released two-year data from the FAME 2 trial comparing the use of the PressureWire technology in patients with stable coronary artery disease compared to those receiving solely standard medical therapy. Patients receiving stenting with the assistance of FFR had a lower rate of death, heart attack or urgent revascularization than those receiving medical therapy alone (8.1% compared to 19.5%).
Boston Scientific ($BSX) is also interested in the FFR market, which it says exceeds $250 million and is growing at a double-digit rate. The competitor recently announced plans for a new FFR guidewire in 2015 in collaboration with Japanese medical components specialist Asahi Intecc.
Finally, the international MORE-CRT study of more than 1,000 patients found the Quartet left-ventricular quadripolar lead to be more effective than bipolar left-ventricular leads, St. Jude said. More than 85% of Quartet patients had freedom from left-ventricular lead-related events, compared to 77% of those on a bipolar lead.
- read the FAMOUS-NSTEMI release about fractional flow reserve technology
- read the FAME 2 release about FFR
- the PressureWire product website
- here's background information about FFR from St. Jude
- read the MORE-CRT release about left-ventricular leads