MEDICAL DEVICE INNOVATION - Medical Device Daily

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38 Mini BP cuff could disrupt surgical monitoring market By JOHN BROSKY Medical Device Daily European Editor DÜSSELDORF, Germany – A small Austrian company introduced an innovation for continuous blood pressure monitoring so simple that, once seen, you have to ask why no one thought to do this before. Yet this elegantly low-tech technique opens a new potential for adding existing technologies that taken together could disrupt the current market for blood measurement during surgery. CNSystems Medizintechnik (Graz, Austria) won FDA approval just one week ahead of the MEDICA 2008 exposition here for its CNAP Monitor 500, which measures arterial blood pressure via a sensor sleeve placed over the patient’s fingers. The monitor has been available for sale in Europe since June. Measuring blood pressure during surgical procedures is critical to monitoring the patient under sedation. When patient blood volume state is maintained in an optimum range, anesthesiology studies show post-operative recovery can be reduced from 17 days to just seven. The trend toward goal-directed fluid volume management is delivering improved patient outcomes and substantial savings for hospitals, which explains the steadily increasing competition and sales for cardiac monitoring in recent years. Currently the only technique for continuous blood monitoring of patients during operations is an invasive needle inserted into an artery that also has the advantage of providing blood gas measures but increases the risks for infection and has potential for damaging the artery The majority of patients in surgery are monitored using the traditional blood pressure cuff placed on the upper arm, which has the advantage of being non-invasive but the disadvantage that a reading can only be obtained every three to five minutes. “This method not only compresses the arm but also occludes the artery, and if you do it every three minutes to step up the frequency, you will have a lot of bruising,” explained Christopher Arbeiter, head of sales and marketing at CNSystems. He said a study conducted by CNSystems among 150 German and 50 Austrian anesthesiologists found continuous monitoring with an arterial needle is used in 18% of procedures while the pressure cuff is used in 82% of surgeries. In its default setting, the CNAP Monitor 500 displays on a large, anti-reflective screen a high-fidelity blood pressure curve, the beat-to-beat blood pressure values, the patient’s pulse rate and then a trend view of blood pressure and pulse rate. MEDICAL DEVICE INNOVATION 2010 With real-time continuous readings, CNSystems is targeting the 82% of procedures that already are non-invasive, using the blood pressure cuff. “We hope to upgrade the anesthesiologists to continuous information and then go after the 18% of arterial needle procedures where there is not a need for blood gas measures,” Arbeiter said. While selling the new monitor to hospitals through its own distributor network, CNSystems also supplies the CNAP Monitor 500 to original medical equipment manufacturers (OEMs). Three German companies who have integrate the unit into their own product lines are Draeger (Lübeck,Germany), Medis Medizinische Messtechnik (Ilmenau, Germany) and Enverdis (Jena). Draeger introduced the monitor at MEDICA as the Infinity CNAP SmartPod. Arbeiter estimated that less than 20% of the company’s current revenues are to these OEMs, “but we just started with Draeger,” he said. Ian Rowley, sales manager for the UK with APC Cardiovascular (Crewe, UK), said that since the European release of the product in June, he has sold six units. Arbeiter said CNSystems was too late to be included in the 2008 budget cycle for German and Austrian hospitals, but that it has had some success getting on the budget cycles for 2009 and that he projects the first strong wave of sales to come toward the end of next year. He said the company is negotiating with distributors for the U.S., but that his approach to the American market is to seek an “optimal market model.” Because this cuff slips over two fingers, there is the obvious possibility of integrating infrared sensors, which would provide oxygen saturation readings, Arbeiter said, explaining that inputs from the finger cuffs can be plugged into any existing surgical monitor. “This would become a very disruptive product for the SpO2 game” that is led by the Masimo (Irvine, California) and Covidien’s (Mansfield, Massachusetts) Nellcor (Boulder, Colorado) unit as the two biggest manufacturers, he said. “They have a good business selling probes, yet we only need to add software to our device to do the same thing, and that is a no-cost add-on feature,” he added. “So we are moving carefully right now in approaching the U.S. market, because there is more than one big company looking to do a crossover of their product with this device,” Arbeiter said. Asian markets are a low priority, he said, adding that the company is looking into opportunities for China, but that the hurdles are so high for entering the Japanese market that it will take some time to conduct required studies. “Europe and the U.S. are our focus, because that is where a company finds 75% of the global sales potential,” Arbeiter said, adding that he believes the sales potential for To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
MEDICAL DEVICE INNOVATION 2010 39 the device in the U.S. is €185 million ($231 million) annually, and that Europe will be significantly less, with Western Europe projected to be €190 million ($112 million). The CNAP Monitor 500 is only the company’s second major product offering, he said. The centerpiece of its sales to date is a device for cardiovascular assessment called the Task Force Monitor, which non-invasively provides real-time diagnosis of neurocardiogenic syncope for measuring the therapeutic effectiveness of CRT-pacemakers, optimization of hypertension therapy, assessment of autonomic neuropathy in diabetes patients and in research and teaching. For 10 years CNSystems’ annual sales have hovered around €14 million ($5 million), Arbeiter said, and the growth curve will be gradual through 2009, when he expects to post a 50% gain to €16 million ($7.5 million). (This story originally appeared in the December 1, 2008, edition of Medical Device Daily.) To subscribe, please call MEDICAL DEVICE DAILY Customer Service at (800) 888-3912; outside the U.S. and Canada, call (404) 262-5547. Copyright © 2010 AHC Media LLC. Reproduction is strictly prohibited.
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