510K Clearance of the New Non Magnetic MRidium™ MRI IV Pump

IRadimed announces 510K Clearance of the New Non Magnetic MRidium™ MRI IV Pump with Integrated Masimo™ SET SpO2 Monitoring

Winter Park, Florida; August 16th, 2009 The United States Food and Drug Administration has granted IRadimed Corporation clearance of its new MRidium™ 3860+ MRI Infusion System with integrated Masimo SET SpO2 Monitoring. Transport to the MRI for Sedation, Critical Care, and Cardiac Patients to date has required multiple pieces of equipment, with hospital infusion pumps and SpO2 being typically not designed to be integrated and functional in the MRI. Clinicians no longer have to remember each time when they get to the door of the MRI to remove their standard hospital SpO2 equipment so that it does not become a dangerous projectile, or risk a patient burn, in the MR environment. IRadimed has innovatively combined two critically needed technologies for the MRI to increase productivity, patient safety, and ease of transport to, from, and within, the MRI.

The Innovative MRidium™ 3860+ MRI Infusion System is the first Non Magnetic IV Pump designed specifically for use in the MRI Environment with Integrated Masimo SET technology. "We chose the Masimo SET technology because it has such an excellent reputation in the marketplace. "Masimo's systems are viewed by most as one of the best monitoring technologies in the world." said Todd Weber, VP Sales and Marketing. Safety in the MR is the primary concern when it comes to meeting needs for required patient care. These risks are all well known, as essential IV and monitoring equipment can: fly into the bore, cause artifacts on the images, become un-reliable during crucial deliveries of medications and monitoring, or shut down completely when needed the most. Use of improper pulse oximeters has caused severe burns to patients due to the high RF fields involved within MR scanners. 'It is critical to have products which have been designed with the utmost care and thorough insight of this harsh and potentially dangerous environment,' said Roger Susi, founder of IRadimed Corporation.

In hospitals all around the globe, the patient population going to the MRI is growing every day. Today, more and more hospitals are eliminating the long IV lines under their MR Scanner Room doors. Recent studies indicate the addition of 15 to 30 feet of IV Extension Sets significantly reduces the alarm times of syringe and IV pumps, making delivery of critical medications risky at best. Patients are coming to MRI with more IV lines and new types of cases, such as stressing the heart, inter-operative procedures, brain lab suites, cancer patients, and sedations with many of these patients needing accurate delivery at lower rates and volumes. The MRidium™System has been designed to meet these changing needs by reducing the risk; there is no need for long IV lines or Syringe pumps placed outside the Magnet Room. No need to remember to remove your standard hospital SpO2 Monitor, because the MRidium™Pump has the ability to maneuver right next to the bore of the MRI and deliver your medications safely and efficiently. All while being monitored through its wireless remote control, which operates inside the MRI control room.

The MRidium™Pump has the ability to work at the 10,000 Gauss magnetic field environment of 1.5 and 3.0 Tesla MR Scanners, and the system includes the remote control ability for adjusting critical medication deliveries and alarm monitoring from outside the MR Scanner room. The safe placement of the pump is of the utmost importance, because these safety-critical Gauss line limits are invisible and different for every magnet design and strength, which makes it difficult to know where the safe limits are in relation to the MR Scanner. The 10,000 Gauss Line is virtually inside the bore of the MR Scanner in many cases, which allows the use of the MRidium™Pump in close proximity to the MR scanner.

The MRidium™System's remote ability allows clinicians to monitor the infusion progress and make changes to the pump from outside the MR scanner room without having to stop the scan; this provides the ability to adjust or bolus critical medications, such as Propofol, which is commonly used for MR Anesthesia, without interrupting, or unnecessarily delaying, the MR scan.

The New MRidium™3860+ System has a number of key new features which make this MR IV Pump simple and safe to deliver even the smallest of infusions. With rate ranges from 0.1 ml to 1400 ml per hour, the MRidium™System is designed to meet all of your infusion needs. Our new 10 digit keypad makes programming a snap, with quick changes at the press of a few buttons. This Smart Infusion System also has an integrated programmable drug library designed for the MRI - making it an indispensible tool for delivery of critical medications such as Dobutamine, Adenosine, Propofol, and Dexmedetomidine. The system also offers a modular second channel which allows for delivery of two medications simultaneously during patient scans. A range of available infusion sets provides the necessary clinical flexibility needed for MRI Infusion. The MRidium™1055 Bypass Infusion set allows clinicians to quickly change over IV sets from the hospital based infusion system without having to disconnect the lines from the patient. The MRidium™1057 Vented Syringe Adapter Set allows for accurate delivery from a syringe using a low priming volume of only 4 milliliters per set.

The MRidium™3860+ MRI IV Pump with Integrated Masimo SET SpO2 Technology is marketed globally through one of our many distributors. To request a demonstration please contact sales@iradimed.com or call: 1-407-677-8022 and ask for the sales department.

About IRadimed Corporation
IRadimed Corporation is a leader in MRI safe products and Infusion Therapy. Our founder is the pioneering developer of both the world's first and best selling MRI compatible monitoring system and the only Non Magnetic IV Pumps designed specifically for use in the MRI Environment. IRadimed's staff has a combined 70+ years developing MRI safe products. The MRidium™ Infusion System has full benefit of the experience and attention to details so important to the development of quality equipment which can be safely used in the MRI setting. For more information please visit www.iradimed.com.

MRidium™is a Trademark of IRadimed Corporation
Masimo and Masimo SET are registered trademarks of Masimo Corporation.

Kevin Jirka