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January 16, 2008 – Transonic Systems Inc. announces today that it has filed a 510K application with the FDA for COstatus™, a cardiac output and blood volume measurement device. COstatus™ offers a fast, safe, reproducible means of measuring cardiac output and blood volumes in infant, pediatric and adults in critical care settings. COstatus™ uses a saline indicator, injected into a tubing set connected to a patient’s in-situ catheters, to measure and calculate Cardiac Output, Cardiac Index, Central Blood Volume Index, Stroke Volume Index, Systemic Vascular Resistance, Total End Diastolic Volume Index and Active Circulation Volume Index.
COstatus™ expands Transonic Systems’ presence in pediatric critical care units where gold standard Transonic flow measurement technology is already used to ensure that infants undergoing extracorporeal membrane oxygenation (ECMO) receive life-saving fluids. In validation studies, COstatus™ measurements agreed well with standard cardiac output pulmonary artery catheter measurements used in adult cardiac critical care units. In addition, COstatus™ blood volume measurements can be used as tools in the assessment of intravascular volume and ventricular preload volume in the critically ill.
Transonic Systems is the global leader in biomedical flow measurement technology. For 25 years its devices have been used for groundbreaking laboratory research and provide quantitative flow measurements during cardiac, vascular, transplant and neurosurgeries, ECMO, angioplasty, and hemodialysis.
COstatus™ offers a fast, safe, reproducible means
of measuring cardiac output and blood volumes in
pediatric patients that can be measured repeatedly
over the course of a patient's illness. The system
works off in-situ catheters and uses innocuous saline
as an indicator. Hence, COstatus™ can be used with
patients of any age or size.
Schulenberg A et al,
"A novel method to measure cardiac output in the
pediatric ICU: animal validation and preliminary clinical study,"
Cirticial Care Medicine 2006: 34: A12 Abstract #46
"Cardiac output measurements from COstatus (COud)
agreed well with the standard thermodilution (COtd)
measuremetns in adult cardiac ICU patients, suggesting
that COud is interchangeable with COtd. Also, Central
Blood Volume Index and Total End Diastolic Volume Index
measured by COstatus™ can be used as tools in the
assessment of the intravascular volume and ventricular
preload volume in the critically ill. The new method does
not involve any surgical invasiveness and the set-up was
between 3-6 minutes."
Eremenko AA, Safarov PN
"Validation of a new cardiac ultrasound dilution method
in cardiac ICU patients," Blood volume assessment during fluid loading by ultrasound dilution method,"
Intensive Care Medicine 2007; 33: S232, Abstracts #0901, 1004
Patient Benefits
Ultrasound Dilution Technology
Gleed RD et al, “Validation of Novel Ultrasound Dilution Cardiac Output Method for Pediatric and Neonatal Patients,” Proceedings of the 19th European Society of Intensive Care Medicine 2006; 32(1): Abstract 0659.
Krivitski, NM, Kislukhin VV, Thuramalla N, “Theory and In-vitro Validation of a New Extracorporeal AV Loop Approach for Hemodynamic Assessment in Pediatric and Neonatal ICU Patients.” Pediatric Critical Care Medicine (Accepted for publication)
Gleed RD, Callahan M, Darling E, Searles B, Kislukhin V, Thuramalla NV, Krivitski, NM, “Validation of Novel Ultrasound Dilution Cardiac Output Method for Pediatric and Neonatal Patients,” Proceedings of the 19th European Society of Intensive Care Medicine. 32(1): Abstr. 0659, Sept. 2006, Barcelona, Spain (Rat, Pig, Sheep, Aorta, Ascending, Pulmonary a)
Schulenberg A, Harmon W, Rubenstein J, Ragosta K, Darling E, Searles B, Thuramalla N, Kislukhin V, Krivitski N, “A Novel Method to Measure Cardiac Output in the Pediatric ICU: Animal Validation and Preliminary Clinical Study,” Crit Care Med 2006; 34(12): Suppl.
Tsutsui M, Matsuoka N, Sanjoh Y, Ikeda T, Tazama T, “Comparison of New Cardiac Output Ultrasound Dilution Method with Thermodilution Technique,” Anesthesiology 2007; 107: A1534.
Thuramalla NV, Kislukhin VK, Krivitski, NM, Callahan MF, Darling E, Searles B, Eremenko AA, Safarov PN, “Quantitative Criteria for Assessment Hemorrhage Using Blood Volumes Measured by Ultrasound Dilution Method,” Intensive Care Medicine 2007; 33: S9 Abstr. 0018.
Krivitski NM, Thuramalla NV, Kislukhin VK, “Novel Ultrasound Dilution Technology to Routinely Measure Blood Volumes in Pediatrics and Neonates (in Vitro Validation),” Intensive Care Medicine 2007; 33: S43 Abstr 0155.
Eremenko, AA, Safarov, PN, “Validation of New Cardiac Output Ultrasound Dilution Method in Cardiac ICU Patients,” Intensive Care Medicine 2007; 33: S232 Abstr 901.
Eremenko, AA, Safarov, PN, “Blood Volume Assessment during Fluid Loading by Ultrasound Dilution Method,” Intensive Care Medicine 2007; 33: S258 Abstr 1004.
Darling E, Searles B, Thuramalla N, Kislukhin V, Krivitski N, “Accuracy of the New Ultrasound Dilution (UD) Method to Measure Cardiac Output (CO) in Neonates and Pediatrics: Animal Validation,” Crit Care Med 2007; 35(12): Suppl Abstr 50.
Dwyer-Matzky K, Harmom W, Schulenberg A, Rubenstein J, “Reproducibility of a Minimally Invasive Method of Assessing Central Blood Volumes in PICU Patients,” Crit Care Med 2007; 35(12): Suppl Abstr. 287.
Eremenko A, Safarov P, “Central Blood Volume Index (CBVI) and Total End Diastolic Volume Index (TEDVI) As An Indicator of Cardiac Preload,” Crit Care Med 2007; 35(12): Suppl Abstr 312.
Eremenko A, Safarov P, “Accuracy and Reproducibility of a New Minimally Invasive Ultrasound Dilution (UD) Method to Measure Central Hemodynamic Parameters in ICU patients,” Crit Care Med 2007; 35(12): Suppl Abstr 319.
Harmom W, Dwyer-Matzky K, Schulenberg A, Rubenstein J, “Can Dilution Methods Be Used to Assess Cardiac Performance in Patients with Complex Congenital Heart Disease? Cardiac Output and Shunt Calculation Following a Fenestrated Fontan Operation,” Crit Care Med 2007; 35(12): Suppl Abstr. 1032.
(Gold Standard Ultrasound Dilution Technology)
HD4T Krivitski, NM, “Novel Method to Measure Access Flow during Hemodialysis by Ultrasound Velocity Dilution Technique,” ASAIO J 2005; 41(3): M741-M745.
HD8T Krivitski, NM, Depner, TA, “Cardiac Output and Central Blood Volume during Hemodialysis: Methodology,” Adv Renal Replace Ther 1999; 6(3): 225-232.
HD15V Nikiforov, UV, Kislouchine, VV, Chaus, NI, “Validation of a New Method to Measure Cardiac Output during Extracorporeal Detoxification,” ASAIO J 1996; 42(5) M903-M905.
HD16V Kislouchine, VV, Dean, DA, “Validation of a Novel Ultrasound Dilution Method to Measure Cardiac Output during Hemodialysis,” ASAIO J 1996; 42(5): M906-M907.
HD6A Sands, JJ, Glidden, D, Miranda, C, “Access Flow Measured during Hemodialysis,” ASAIO J 1996; 42(5): M530-M532.
HD89A Pandeya, S, Lindsay, RM, "The Relationship between Cardiac Output and Access Flow during Hemodialysis." ASAIO J 1999; 45(3): 135-138.
HD93A Leypoldt, JK, Lindsay, RM, “Hemodynamic Monitoring during Hemodialysis,” Adv Renal Replace Ther 1999; 6: 233-242.
HD249A Hoeben, H., Abu-Alfa, A.K., Mahnensmith, R., Perazella, M.A., "Hemodynamics in patients with intradialytic hypotension treated with cool dialysate or midodrine," American Journal of Kidney Diseases, Vol. 39, No. 1, p. 102-107, 2002.
HD264A Prakash, S, Reddan D., Heidenheim, AP, Kianfar, Lindsay, RM. “ Central, peripheral and other blood volume changes during hemodialysis,” ASAIO J 2002; 48(4): 379-382.
HD302A Rivera, R, Bonforte, G, Zerbi, S, Orani, A, Mircoli, L, Mandolfo, S, Arrigo, G, “Cardiac and Hemodynamic Response to Standard Bicarbonate Hemodialysis,” 9th European Meeting on Cardionephrology 2002; 345-348.
HD378A MacRae, JM, Pandeya, S, Humen, D, Krivitski N, Lindsay RM, “Arteriovenous fistula-associated high-output cardiac failure: a review of mechanisms,”Am J Kidney Dis 2004; 43(5): 17-22.
HD7355A Chemla ES, Morsy M, Anderson L, Whitemore A, “Inflow reduction by distalization of anastomosis treats efficiently high-inflow high-cardiac output vascular access for hemodialysis,” Semin Dial 2007; 20(1):68-72.
HD7337A MacRae JM, Leven, Andeera, Belenkie, “The Cardiovascular Effects of Arteriovenous Fistulas in Chronic Kidney Disease: A Cause for Concern?” Semin Dial 2006; 19(5): 349-3562.
HD7336A MacRae JM, “Vascular access and cardiac disease: is there a relationship?” Curr Opin Nephrol Hypertens 2006; 15(6): 577-82.
HD243A Ondocin, PT, Harish, D, Narsipur, SS., "The influence of beta blockade on autonomic neuropathy and cardiovascular function in patients on hemodialysis (HD)," JASN Abstracts 2001; 12: 404A.
HD240A Harish, D, Ondocin, PT, Narsipur, SS, "The influence of an angiotensin converting enzyme inhibitor (ACEI) on autonomic neuropathy and cardiovascular function in patients on hemodialysis (HD)," JASN Abstracts 2001; 12: 382A.
HD220A Hoeben, H, Abu-Alfa, AK., Mahnensmith, R, Perazella, MA., "Hemodynamic measurements in patients with IDH on therapy with either cool dialysate or midodrine," JASN Abstracts 2001; 12: 384A.
HD74A Pandeya, S, Lindsay, RM, “Cardiac Output and Access Flow during Hemodialysis [HD]: Are They Related?” JASN Abstracts 1998; 9: 179A.
HD3T Krivitski, NM, “Cardiac Output Measurement in Extracorporeal Systems by Ultrasound Velocity Dilution,” ASAIO Abstracts 1994; 40: 82.
HD23A Depner, TA, Krivitski, NM, “Influence of Access Blood Flow (AF) on Systemic Blood Flow in Hemodialysis Patients,” JASN Abstracts 1997; 8: 155A.
HD58A Depner, T, Ganel, J, Kislukhin, V, Krivitski, NM, “Peripheral Resistance and Systemic Blood Flow in Hemodialysis Patients,” JASN Abstracts 1998; 9: 170A..
HD50A Pandeya, S, Lindsay, RM, “The Relationship between Cardiac Output and Access Flow during Hemodialysis,” ASAIO J 1998; 44(2): 64A.
HD5T Krivitski, NM, Depner, TA, “Central Blood Volume Monitoring - New Technology for Hemodialysis,” JASN Abstracts 1996; 7(3) 1517..
HD15A Depner, TA, Krivitski, NM, “Central Blood Volume: A New Criterion for Predicting Morbid Events during Hemodialysis,” JASN Abstracts1996; 7(9): 1511.
HD95A Krivitski, N.M., Kislukhin, V., Snyder, J., Depner, T., "Measurement of Cardiac Output and Central Blood Volume during Hemodialysis: Sources of Error." 25th International Congress of Nephrology Abstract, p. 333. May 1999.
HD108A Huu, T. C., Suty-Selton, C., Bellou, M., Ladriere, M., Juilliere, Y., Kessler, M., "Access Flow (Qac) and Cardiac Output (CO) Measurements by Non-Invasive Methods in Hemodialysed Patients." Angioaccess for Hemodialysis, 2nd International Multidisciplinary Symposium. May 31-June 2, 1999, p. 170.
HD50V Huu, T.C., Suty-Shelton, C., Bellou, M., Frimat, L., Juilliere, Y., Kessler, M., “Non-Invasive Measurement of Access Flow (Qac) and Cardiac Output (CO) in Hemodialysis Patients," Nephrology Dialysis Transplantation, Vol. 14, No. 9, p. A175, 1999
HD42V Barril, G., Cirugeda, A., Fdez Perpen, A., Alvarez, V., Bernis, C., Schez Tomero, J.A., Traver, J.A., Selgas, R., "Vascular Access (VA) Assessment by Dilutional Methodology (Transonic QC)," JASN Abstracts, Vol. 10, p. 201A, 1999.
HD129A Huu, T.C., Suty-Selton, C., Panescu, V., Achicha, M., Juilliere, Y., Kessler, M., Brabois, C.H.U., "Detection of High Access Flow (Qac) and Cardiac Output (CO) in Hemodialysed Patients," JASN Abstracts, Vol. 10, p. 202A, 1999.
HD131A Schneditz, D., Haditsch, B., Krisper, P., Kenner, T., Hinghofer-Szalkay, H., Wang, E., Levin, N.W., "Systematic Underestimation of Cardiac Output by Thoracic Bioimpedance in Hemodialysis Patients: Relation to Access Blood Flow," JASN Abstracts, Vol. 10, p. 217A, 1999.
HD154A Depner, T.A., Kislukhin, V.V., Krivitski, N.M., “Contraction of Central Blood Volume and Reduced Cardiac Index in Hemodialyzed Diabetic Patients,” JASN Abstracts, Vol. 11, No. 3, p. 263A, 2000.
HD155A Dobson, A., Kislukhin, V.V., Krivitski, N.M, Depner, T.A., “Cardiac End Diastolic Blood Volume from Cardiac Output during Dialysis,” JASN Abstracts, Vol. 11, No. 3, p. 264, 2000.
HD156A Kiaii, M., Kianfar, A., Heidenheim, A., Lindsay, R.M., “What “Blood Volume” Do We Dialyze?,” JASN Abstracts, Vol. 11, No. 3, p. 277, 2000.
HD268A Tucker T., Nadolski, S., Smith, I., Hamilton, T., Lasseter, P., “Central Hemodynamic (CH) Profiling during Outpatient Hemodialysis (HD),” JASN Abstracts, Vol. 13, p. 209A, 2002.
HD267A Tucker, T., Nadolski, S., Smith, I., Lasseter, P., Hamilton, T., “Unrecognized Deterioration of Cardiac Function during Hemodialysis,” JASN Abstracts, Vol. 13, p. 213A, 2002.
HD335A Haditsch, B., Waber, P., Krisper, P., Holzer, H., Schneditz, D., “Cardiac Output during Hemodialysis,” JASN Abstracts, Vol 14, p. 487A, 2003.
HD334A Yue, S.V., Chin, A.I., Depner, T.A., “Differences in Cardiac Output in Hemodialysis Patients with Grafts Versus Native Fistulae,” JASN Abstracts, Vol 14, p. 722A, 2003.
HD388A van der Mark, W., Boer, P., Blankenstijn, P.J., Blood Flow in Brachiocephalic AVF Represents a Greater Percentage of Cardiac Output Than That in Radiocephalic AVF,” ASN Abstracts 2004
HD386A Jensen, D., Jensen., J.D., “Cardiac Output (CO) Monitoring during Haemodialysis (HD) a Comparison between Saline Dilution Method (Transonic), and a Noninvasive Method Based on Rebreathing of Inert Gas (Innocor),” ASN Abstracts 2004 [SUPO-363]
HD7331A Thomas M. Kitzler, Olga Sergeyeva, Peter Kotanko, Nathan W. Non-Invasive Measurement of Cardiac Output in Hemodialysis Patients by Task Force Monitor: A Comparison with the Transonic System Levin Renal Research Institute, New York, NY, JASN. Abstracts 2006 [F-PO711]
