Prescribing Info and Product Literature

                 

Peer-Reviewed Studies and Articles

T-Stat was the first device to be approved by the FDA as "sensitive to ischemia". Highlight articles are provided below, a larger number of additional articles, abstracts, and studies are available on request.

         

Neonatal ICU                                                                                                    

► Cerebral Ischemia more sensitively detected by T-Stat® than by NIRS  (2006). Use of T-Stat® to detect cerebral ischemia cardiac repair, especially of cortical versus deep matter saturation, was demonstrated.
      J Thorac Cardiovasc Surg. 2006 Dec;132(6):1307-1313.

► Somatic Ischemia Monitored During Cardiac Surgery  (2006). Use of T-Stat® to detect somatic ischemia during cardiac repair was demonstrated.
      Paediatr Anaesth 2006 Nov;16(11):1133-1137.

► Validation of the T-Stat® Platform for the in vivo Detection of Ischemia  (2004). Validation of the T-Stat® during normoxia, hypoxemia, and ischemia.
      Anesthesiol 2004 Jun;100(6):1469-1475 ( medline ).

► T-Stat® Prospectively Detects Tissue and Organ Ischemia During Cardiac Bypass  (2004). Animal study demonstrating T-Stat® predicts cerebral ischemia during cardiac surgery on cardiopulmonary bypass.
      Amer Soc Anesthesiology 2004 (abstract).

Shock

► Mesenteric Ischemia Treatment Guidance Using T-Stat®  (2007). Use of T-Stat® allowed mesenteric ischemia to be diagnosed and treated, suggesting application to a variety of gut ischemia issues that can be resolved through interventional treatment such as arterial stenting.
      Gastrointest Endosc 2007 Feb;65(2):294-300.

► Cerebral Ischemia more sensitively detected by T-Stat® than by NIRS  (2006). Use of T-Stat® to detect cerebral ischemia cardiac repair, especially of cortical versus deep matter saturation, was demonstrated.
      J Thorac Cardiovasc Surg. 2006 Dec;132(6):1307-1313.

► Somatic Ischemia Monitored During Cardiac Surgery  (2006). Use of T-Stat® to detect somatic ischemia during cardiac repair was demonstrated.
      Paediatr Anaesth 2006 Nov;16(11):1133-1137.

► Validation of the T-Stat® Platform for the in vivo Detection of Ischemia  (2004).Validation of the T-Stat® during normoxia, hypoxemia, and ischemia.
      Anesthesiol 2004 Jun;100(6):1469-1475 (  medline ).

► T-Stat® Prospectively Detects Tissue and Organ Ischemia During Cardiac Bypass  (2004). Animal study demonstrating T-Stat® predicts cerebral ischemia during cardiac surgery on cardiopulmonary bypass.
      Amer Soc Anesthesiology 2004 (abstract).

► T-Stat® Prospectively Detects Ischemia During Vascular Surgery  (2004). Prospective human clinical study demonstrating T-Stat® detects ischemia during vascular surgery.
      Soc Interventional Radiol 2004 (abstract)

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G.I. Endoscopy

► T-Stat® for Assessment of Perfusion in Rectal Anastomosis  (2007). T-Stat® monitored tissue viability during colonic rectal surgery requiring anastomosis
      Eur Surg Res 2007;39(supp 1):O 025 (abstract)

► Intra-operative Assessment of Tissue Viability (2007). Use of T-Stat® monitored tissue viability during Bariatric surgery.
      Presented at the SSAT/DDW, Washington DC.

► Use of T-stat to Predict Colonic Ischemia during and after Endovascular Aneurysm Repair: A case report (2007). T-Stat® monitored tissue viability during vascular surgery.
      J Vasc Surg 2007; in press.

► Mesenteric Ischemia Treatment Guidance Using T-Stat® (2007). Use of T-Stat® allowed mesenteric ischemia to be diagnosed and treated, suggesting application to a variety of gut ischemia issues that can be resolved through interventional treatment such as arterial stenting.
      Gastrointest Endosc 2007 Feb;65(2):294-300.

► Colon Ischemia Ruled Out as Factor in Post-Radiation Proctitis (2006). Use of T-Stat® to detect colon ischemia after radiation treatments was demonstrated.
    Endoscopy. 2006 May;38(5):488-92.

► Chronic Mesenteric Ischemia Diagnosable Endoscopically Using T-Stat®  (2005). Use of T-Stat® to detect and monitor treatment of chronic mesenteric ischemia.
      DDW 2005 (abstract).

► Detection of Gut Ischemia Using T-Stat® During Endoscopy (2004). Use of T-Stat® to detect gastrointestinal ischemia during endoscopy.
      Gast Endo Clin N Am 2004;14(3):539-553 ( medline).

► Validation of the T-Stat® Platform for the in vivo Detection of Ischemia  (2004).Validation of the T-Stat® during normoxia, hypoxemia, and ischemia.
      Anesthesiol 2004 Jun;100(6):1469-1475 ( medline).

► T-Stat® Detects Ischemia  (2003). Human gastrointestinal tract oxygenation can be monitored using T-Stat®. Tissue hypoxia, can be detected, whether from hypoxemia or ischemia.
      Gastro Endosc 2003 Apr;57(4):492-497 ( medline )

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Vascular Surgery                                      

► Use of T-stat to Predict Colonic Ischemia during and after Endovascular Aneurysm Repair: A case report (2007). T-Stat® monitored tissue viability during vascular surgery.
      J Vasc Surg 2007; in press.

► Mesenteric Ischemia Treatment Guidance Using T-Stat®  (2007). Use of T-Stat® allowed mesenteric ischemia to be diagnosed and treated, suggesting application to a variety of gut ischemia issues that can be resolved through interventional treatment such as arterial stenting.
      Gastrointest Endosc 2007 Feb;65(2):294-300.

► Aortic Repair Colon Ischemia Improved Using T-Stat®  (2005). Use of T-Stat® to detect colon ischemia during AAA repair led to reduced death rates and length of ICU stays.
      Anesthesiology 2005;103:A349 (abstract).

► Chronic Mesenteric Ischemia Diagnosable Endoscopically Using T-Stat®  (2005). Use of T-Stat® to detect and monitor treatment of chronic mesenteric ischemia.
    DDW 2005 (abstract).

► Validation of the T-Stat® Platform for the in vivo Detection of Ischemia  (2004). Validation of the T-Stat® during normoxia, hypoxemia, and ischemia.
      Anesthesiol 2004 Jun;100(6):1469-1475 ( medline).

► T-Stat® Prospectively Detects Tissue and Organ Ischemia During Cardiac Bypass (2004). Animal study demonstrating T-Stat® predicts cerebral ischemia during cardiac surgery on cardiopulmonary bypass.
      Amer Soc Anesthesiology 2004 (abstract).

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Cerebral Monitoring

► Cerebral Ischemia more sensitively detected by T-Stat® than by NIRS (2006). Use of T-Stat® to detect cerebral ischemia cardiac repair, especially of cortical versus deep matter saturation, was demonstrated.
      J Thorac Cardiovasc Surg. 2006 Dec;132(6):1307-1313.

► Somatic Ischemia Monitored During Cardiac Surgery (2006). Use of T-Stat® to detect somatic ischemia during cardiac repair was demonstrated.
      Paediatr Anaesth 2006 Nov;16(11):1133-1137.

► Validation of the T-Stat® Platform for the in vivo Detection of Ischemia (2004). Validation of the T-Stat® during normoxia, hypoxemia, and ischemia.
      Anesthesiol 2004 Jun;100(6):1469-1475 ( medline).

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Cancer Research

► Tumors Detectable Endoscopically Using T-Stat®  (2005). VLS tissue oximetry can distinguish neoplastic tissue from normal tissue with a high specificity, potentially aiding endoscopic detection of gastrointestinal tumors.
      Technol Canc Res Treat. 2005 Jun;4(3):227-234 ( medline).

► Design and Operation of the T-Stat® (2005). Design and benchtop validation of T-Stat®.
      J Biomed Optics 2005; Jul/Aug 10(4) ( medline).

► Monitoring RF Tumor Ablation in vivo 2005). Use of T-Stat® to detect ablation in tumors.
      J Vasc and Interven Radiol 2005;16:1473-1478 ( medline).

► Detection of Tumor Ischemia During Electroporation of Tpz Chemotherapy Using T-Stat® (2004). Use of T-Stat® to detect changes in tumor oxygenation during electrical delivery of chemotherapy.
      Radiation Res 2004 Jul;162: 185-193 ( medline)

► Validation of the T-Stat® Platform for the in vivo Detection of Ischemia (2004). Validation of the T-Stat® during normoxia, hypoxemia, and ischemia.
      Anesthesiol 2004 Jun;100(6):1469-1475 ( medline).

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Cardiac Surgery, Plastic Surgery, Bariatric Surgery, Other Surgery                    

► T-Stat® for Assessment of Perfusion in Rectal Anastomosis (2007). T-Stat® monitored tissue viability during colonic rectal surgery requiring anastomosis
      Eur Surg Res 2007;39(supp 1):O 025 (abstract)

► Intra-operative Assessment of Tissue Viability (2007). Use of T-Stat® monitored tissue viability during Bariatric surgery.
      Presented at the SSAT/DDW, Washington DC

► Cerebral Ischemia more sensitively detected by T-Stat® than by NIRS (2006). Use of T-Stat® to detect cerebral ischemia cardiac repair, especially of cortical versus deep matter saturation, was demonstrated.
      J Thorac Cardiovasc Surg. 2006 Dec;132(6):1307-1313.

► Somatic Ischemia Monitored During Cardiac Surgery (2006). Use of T-Stat® to detect somatic ischemia during cardiac repair was demonstrated.
      Paediatr Anaesth 2006 Nov;16(11):1133-1137.

► Validation of the T-Stat® Platform for the in vivo Detection of Ischemia (2004). Validation of the T-Stat® during normoxia, hypoxemia, and ischemia.
      Anesthesiol 2004 Jun;100(6):1469-1475 ( medline).

► T-Stat® Prospectively Detects Tissue and Organ Ischemia During Cardiac Bypass (2004). Animal study demonstrating T-Stat® predicts cerebral ischemia during cardiac surgery on cardiopulmonary bypass.
      Amer Soc Anesthesiology 2004 (abstract).

► T-Stat® Prospectively Detects Ischemia During Vascular Surgery (2004). Prospective human clinical study demonstrating T-Stat® detects ischemia during vascular surgery.
      Soc Interventional Radiol 2004 (abstract)

► T-Stat® Experience During Cardiac Bypass Surgery (2003). First experiences using T-Stat® During Cardiopulmonary Bypass During Cardiac Surgery.
      Anesthesiology 2003;99:A558 (abstract).

► T-Stat® During Plastic Surgery Detects Ischemia (2003). Monitoring oxygenation of the skin flaps during plastic surgery allowed detection of skin regions later going on to develop ischemia using T-Stat®
      Amer Derm Surg Assoc 2003 (abstract).

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