Edwards Lifesciences Corporation (EW) received 510 (k) clearance from the US Food and Drug Administration (FDA) for its EV1000 clinical monitoring platform.
The device is meant to help physicians make prompt and judicious decisions in the operating room.
Edwards is one of the leading players in hemodynamic monitoring equipment, used to measure a patient's heart function in surgical and intensive care settings. The need to monitor arises before, during and after open-heart, major vascular, major abdominal, neurological and orthopedic surgical procedures. The company also offers the Flotrac continuous cardiac output monitoring system, a minimally invasive cardiac monitoring technology.
In late 2010, Edwards introduced its VolumeView sensor-catheter set and EV1000 clinical monitoring platform in Europe and Australia, which expanded the medical intensive care portfolio. During the first quarter of fiscal 2011, sales of Critical Care increased 14.8% year over year, which came in at $120.6 million. Strong sales of advanced monitoring products led by Flotrac systems and pressure monitoring products contributed to the growth.
The company expects Critical Care to record revenues at the higher end of a $470−$500 million range, resulting in 5%−8% underlying sales growth in 2011, driven by ongoing growth of advanced monitoring products and the recent launch of VolumeView and EV1000. With these products fetching positive clinician feedback, they could drive market share going ahead. Approval of EV 1000 in US should result in higher revenues from the segment in the forthcoming period. Moreover, Edwards is making progress with respect to second generation product of its glucose monitoring program and expects to receive CE Mark approval by the end of 2011.
While it is encouraging to note that the Critical Care segment is on a growth path, Edwards records the majority of its revenues from the Heart Valve Therapy segment. In this respect, the company is awaiting an FDA panel’s recommendation for its Sapien transcatheter heart valve (THV), scheduled on July 20, 2011. However, the company operates in a highly competitive environment with many big players such as Medtronic (MDT) and Boston Scientific (BSX) targeting the THV business.
We are currently ‘Neutral’ on Edwards, which also corresponds to Zacks #3 Rank (hold) in the short term.
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