|
Mortara Instrument Announces Expanded Capabilities of VERITAS Resting ECG Interpretation Algorithm MILWAUKEE, WI, February 2, 2009 - Today Mortara Instrument announced its receipt of FDA 510(k) clearance to market an enhanced version of its VERITAS™ resting ECG interpretation algorithm that incorporates pediatric criteria. The addition of pediatric criteria to the VERITAS algorithm will extend the diagnostic utility of Mortara's ELI™ 350 electrocardiographs with specific interpretive statements based on age criteria that ranges from weeks to teenage years.
"We are proud to announce this important algorithm development. The addition of pediatric criteria to our well established VERITAS algorithm will significantly enhance its utility in many different care environments," stated Dr. Justin L. Mortara, CEO of Mortara Instrument. "Over the years we have seen an ever increasing need to introduce a pediatric algorithm, not least of which to better serve the evaluation of children and young adults for potentially life-threatening cardiac abnormalities. Our introduction of this pediatric algorithm, matched with Mortara's best-in-class signal acquisition technology, will set the ELI 350 electrocardiograph in a class by itself." The current generation of Mortara ELI electrocardiographs exceed the recommended frequency response for pediatric ECGs as stated in the 2007 ACC/AHA/HRS Scientific Statements* where the authors noted, "To measure routine durations and amplitudes in adults, adolescents, and children, an upper-frequency cutoff of at least 150 Hz is required; an upper-frequency cutoff of 250 Hz is more appropriate for infants." All Mortara ELI electrocardiographs provide an upper-frequency cutoff of 300 Hz, whereas most electrocardiographs generally only meet the 150 Hz adult recommendation. In addition to announcing its pediatric algorithm, the company has begun offering a 15-lead option for its ELI 350 electrocardiograph. The 15-lead capability adds support for additional pediatric-specific lead placements or alternate lead placements for adults. Dr. Mortara concluded, "We look forward to better serving our customers with these important new developments as well as more offerings to come in 2009. Our teams are busy at work changing the way ECGs are performed; moving ahead and showing how we truly can improve how things are done everyday in the world of the ECG." *Kligfiel P, Gettes LS, et.al. Recommendations for the Standardization and Interpretation of the Electrocardiogram, J Am Coll Cardiol 2007; 49:1109-27.
- Source: www.mortara.com
|