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170 RBC Incidents

1,000 Heart Case Example

Incremental Cost of RBC/Patient

$28,080

Revenue Lost to RBC

~4.77MM

32 Fr Conventional Chest Tube Obstructed by Thrombus

Retained Blood Complex●● Incomplete evacuation of blood from the pleural and pericardial spaces after heart surgery can lead to a complex of acute, or sub-acute retained blood complications that include any combination of:

Hemothorax

Pericardial Tamponade

Pericardial Effusion

Pleural Effusion●● This retained blood complex (RBC) can increase complications, mortality, cost of care, and readmission rate.2

Burden of Retained Blood†

●● 17% of adult cardiac surgery inpatients have RBC complications.●● RBC patients have:

Doubled mortality rates

5 days longer length of stay

55% higher total costs

Chest Tube Obstruction●● 36% of cardiac surgery patients have obstructed chest tubes, 86% of which are not visible to caregivers.4

●● Small thrombus obstructions can significantly im-pair evacuation causing blood to be retained in the pleural and pericardial spaces.

RETAINED BLOOD COMPLEX

1 Arakaway, Yoko, Akira Shiose, Tohru Takaseya, Hideyuki Fumoto, Hyun-Il Kim, Edward M. Boyle, A. Marc Gillinov, and Kiyotaka Fukamachi. “Superior Chest Drainage with an Active Tube Clearance System: Evaluation of a Downsized Chest Tube.” The Annals of Thoracic Surgery 91 (2011): 580-83.

2 Dixon, Barry, John D. Santamaria, David Reid, Marnie Collins, Thomas Rechnitzer, Andrew E. Newcomb, Ian Nixon, Michael Yii, Alexander Rosalion, and Duncon J. Campbell. “The Association of Blood Transfusion with Mortality after Cardiac Surgery: Cause or Confounding.” Transfusion (2012): 1-9.

3 Shiose, A, T Tokasesya, H Fumoto, Y Arakawa, T Horai, E M Boyle, A M Gillinov, K Fukamachi. “Improved Drainage with Active Chest Tube Clearance.” Interactive Cardiovascular and Thoracic Surgery. 10(5): 685-88

4. Karimov, Jamshid, A. Mark Gillinov, Laura Schenck, Myra Cook, Denise Kosty Sweeney, Edward Boyle, and Kiyotaka Fukamachi. “Incidence of Chest Tube Clogging After Cardiac Surgery: A Single-Center Prospective Observational Study. Eur J Cardiothorac Surg (In Press).

† Analysis performed by Fletcher Spaght, Inc, using Heart Surgery ICD-9 codes to extract data from the 2010 Nationwide Inpatient Sample (NIS), from the DHHS Agency for Healthcare Research and Quality (AHRQ), Healthcare Cost and Utilization Project (HCUP). Report on file at CCS.

PLEURAL EFFUSION

HEMOTHORAX

PERICARDIAL EFFUSION

PERICARDIAL TAMPONADE

Conventional Chest Tube

Skin SuturesPleuraFlow Chest Tube

* PleuraFlow ACT System includes a straight silicone chest tube and clearance apparatus

Code DescriptionPF-20 20 Fr PleuraFlow ACT System*

PF-24 24 Fr PleuraFlow ACT System*



PFC-20S 20 FR PlueraFlow Straight Silicone Chest Tube




Safe, Sterile, Simple●● Magnetic Drive to manipulate internal Clearance Loop●● Safe, simple, and tactile control

●●Maintains sterile environment

Uninhibited Flow●● Clearance Loop allows uninhibited flow●● Real-time patency assessment●● Clears thrombus obstructions toward the drainage canister

CLEARING THE PATHWAY TO RECOVERY

Improved Blood Evacuation●● PleuraFlow Active Clearance Technology (ACT)enables active clearance of chest tube obstructions.●● PleuraFlow ACT provides improved, and more complete evacuation of blood postoperatively.1,3

●● PleuraFlow ACT facilitates real-time assessment of chest tube patency.

©2012 Clear Catheter Systems, Inc. ™Trademarks and ®Registered Trademarks of Clear Catheter Systems, Inc.

USA Patents 7,854,728; 7,951,243; 8,048,233; International Patents CA2,565,303; CA2,712,438; CA 2,427,628; AU 2002236549; AU 2004235782; AU 209229185; ZA 205/9801; EU 1414413. Other patents pending.

US FDA 510(k): K093565; Health Canada License Number 82994

[email protected] ● 541-382-2533www.pleuraflow.com

Ordering Information

Email: [email protected] Phone: 541-382-2533

Manufactured By: Clear Catheter Systems, Inc 62915 NE 18th Street, Suite 5 Bend, OR, US, 97701

ML004-C

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