Edwards Lifesciences Monitor Gets FDA Nod

Zacks

CA-based global leader in the science of heart valves and hemodynamic monitoring – Edwards Lifesciences Corporation (EW) – has received the U.S. Food and Drug Administration (:FDA) approval for its ClearSight hemodynamic monitoring system.

Following the news, Edwards Lifesciences’ share price rose 1.5% to eventually close at $87.14 on yesterday.

Hemodynamic monitoring is the process of measuring blood circulation - in veins and arteries as well as a person's cardiac function. It allows physicians to estimate whether an individual's organs and tissues are receiving adequate oxygen, so as to function properly.

This procedure also enables healthcare providers to check how well an individual's heart is pumping by measuring the total blood flow per minute. This test facilitates detection of cardiac problems at an early stage so that preventive measures can be taken before complications arise.

ClearSight System and Benefits

Edwards Lifesciences' ClearSight system is the most advanced non-invasive hemodynamic monitor that amplifies a physician's access to a patient's advanced hemodynamic parameters, without complex impediments or invasive procedures.

The ClearSight system is connected to a patient by wrapping an inflatable cuff around the finger. The cuff is connected to the Edwards EV1000 clinical platform – an interface system designed to present a patient's physiologic information.

This system furnishes valuable blood volume and blood flow information for patients who are at moderate or high risk of post-surgical complications and are not fit for invasive monitoring.   

It provides up-to-the minute hemodynamic information with a non-invasive approach for a broader patient population, including elderly and obese patients, in whom an arterial catheter could not be inserted.

As a revolutionary breakthrough, ClearSight system can also be used for the non-invasive monitoring of blood pressure of astronauts in space, incorporating Edwards Lifesciences' gold-standard monitoring technologies, a finger cuff and the necessary software.

Since this procedure avoids the traditional invasive approach of monitoring one's blood pressure, it has the capability to expand the benefits of hemodynamic optimization, or proper fluid administration and balance within a patient's organs and tissues, to those who need close monitoring but in a non-invasive manner.

As per empirical evidences, the use of ClearSight monitoring system has resulted in improved patient outcomes, associated with reduced post surgery complications, shorter hospital stays and lower healthcare costs.

It is worth noting that ClearSight is already available in CE Mark countries. The FDA approval marks yet another milestone achievement for Edwards Lifesciences.

Zacks Rank

Edwards Lifesciences currently has a Zacks Rank #3 (Hold). Some better-ranked stocks worth considering in the medical sector include ANI Pharmaceutical, Inc. (ANIP), Akorn, Inc. (AKRX) and Enzo Biochem Inc. (ENZ). All these stocks carry a Zacks Rank #1 (Strong Buy).

Read the Full Research Report on EW
Read the Full Research Report on ENZ
Read the Full Research Report on AKRX
Read the Full Research Report on ANIP


Zacks Investment Research

View Comments (0)