Knot Pusher

• Product code: KP1
• Indications: Intended for use in thoracic surgery in advancing throws of extracorporeal knots to a surface or object into the thoracic cavity
• No contraindications
• No complications

Soft Tissue Retractor

• Product code: TRS,TRM,TRL
• Indications: Designed to be inserted into an intercostal incision to retract tissue to form a port.
• No Contraindications
• No Complications

Valve Placement Pack

• Product code: VPP
• Indications:
  • Knot Pusher: Used to advance throws of extracorporeal knots to a surface or object into the thoracic cavity
  • Valve Probe: Used to test the leaflet motion of a mechanical heart valve during a valve replacement procedure
  • Valve Seater: Used to advance and seat a prosthetic heart valve during a valve procedure
• No contraindications
• No complications

EndoPlege Sinus Catheter

• Product code: EP
• Indications: Indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass
• No contraindications
• Complications:
  • Injury to the internal jugular vein, including perforation
  • Injury to the vena cavae or right atrium
  • Injury to the coronary sinus, including perforation
  • Injury to the tricuspid valve
  • Injury to the right ventricle, including perforation
  • Arrhythmia
  • Hemorrhage
  • Infection/sepsis
  • Pain at insertion site
  • Hematoma at insertion site
  • Venous thrombosis
  • Cardiac failure
  • Death

Steerable Coronary Sinus Catheter

• Product code: SCS01
• Indications: Indicated for occlusion of the coronary sinus, delivery of cardioplegic solution, and monitoring of coronary sinus pressure during cardiopulmonary bypass
• No contraindications
• Complications:
  • Injury to major vessels
  • Injury to the coronary sinus, including perforation
  • Injury to the tricuspid valve
  • Injury to the right ventricle, including perforation
  • Pneumothorax
  • Arrhythmia
  • Hemorrhage
  • Infection/sepsis
  • Pain at insertion site
  • Hematoma at insertion site
  • Venous thrombosis
  • Embolism
  • Cardiac failure
  • Death
  • Reaction to contrast media (refer to contrast media manufacturer's package insert for appropriate use and risks)

• Product codes: SS23A, SS23S
• Indications:
  • Direct Arterial Cannula: Intended for use in patients undergoing cardiopulmonary bypass to deliver oxygenated blood for cardiopulmonary bypass
  • AutoIncisor Introducer: Intended for use with PORT ACCESS arterial cannulae for incising the aorta and introducing the new cannula into the aorta
• Contraindications: Do not use the direct arterial cannula or the AutoIncisor introducer if the patient has severe aortic atherosclerosis or is otherwise contraindicated for cardiopulmonary bypass
• Complications and Side Effects:
  • Bleeding from aortotomy
  • Injury to the aorta, including hematoma, perforation, and dissection
  • Plaque embolization
  • Air embolization

• Product codes: ICF100
• Indications: Intended to occlude and vent the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure
• Contraindications:
  • Relative:
    • Moderate to severe peripheral or aortic atherosclerosis
    • History of thoracic trauma
  • Absolute:
    • Aneurysm of the ascending aorta
    • Severe aortic regurgitation
• Complications:
  • Injury to the artery through which it is inserted, and/or aorta including perforation and dissection
  • Plaque embolization
  • Damage to the aortic valve
  • Stroke
  • Allergic reaction to contrast medium
  • Wound infection/sepsis
  • Pain at insertion site
  • Hematoma at access site
  • Arrhythmia
  • Arterial thrombosis
  • Cardiac failure
  • Death
  • Peripheral nerve damage

• Product codes: EC1001, EC65
• Indications: Intended to occlude and vent the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure
• Contraindications:
  • Relative:
    • Moderate to severe peripheral or aortic atherosclerosis
    • History of thoracic trauma
  • Absolute:
    • Aneurysm of the ascending aorta
    • Severe aortic regurgitation
• Complications:
  • Injury to the artery through which it is inserted, and/or aorta including perforation and dissection
  • Plaque embolization
  • Damage to the aortic valve
  • Stroke
  • Allergic reaction to contrast medium
  • Wound infection/sepsis
  • Pain at insertion site
  • Hematoma at access site
  • Arrhythmia
  • Arterial thrombosis
  • Cardiac failure
  • Death
  • Peripheral nerve damage

Product codes: ER21, ER23

• Indications: The EndoReturn arterial cannula is indicated for patients undergoing cardiopulmonary bypass to deliver oxygenated blood. The EndoReturn cannula with hemostasis valve allows for hemostatic introduction and removal of the EndoClamp aortic catheter
• Contraindications: Do not use the EndoReturn cannula if the patient has severe peripheral atherosclerosis or is otherwise contraindicated for cardiopulmonary bypass
• Complications:
  • Injury to vessel and/or aorta, including perforation
  • Plaque embolization
  • Wound infection/sepsis
  • Pain at insertion site
  • Hematoma
  • Arterial thrombosis
  • Arterial dissection
  • Death

Product codes: AC19, IS19

• Indications:
  • Arterial Cannula, 19 Fr: Indicated for patients undergoing cardiopulmonary bypass to deliver oxygenated blood for cardiopulmonary bypass during surgery
  • Catheter Introducer Sheath: Indicated for patients requiring introduction of catheters for the hemostatic introduction and removal of the EndoClamp aortic catheter
• Contraindications: Do not use the arterial cannula, 19 Fr or catheter introducer sheath if the patient has severe peripheral atherosclerosis or is otherwise contraindicated for cardiopulmonary bypass
• Complications:
  • Injury to vessel and/or aorta, including perforation
  • Plaque embolization
  • Wound infection/sepsis
  • Pain at insertion site
  • Hematoma
  • Arterial thrombosis
  • Arterial dissection
  • Death

• Product code: EV
• Indications: Indicated for patients undergoing cardiopulmonary bypass to remove blood from the pulmonary artery and assist in decompressing the heart
• No contraindications
• Complications:
  • Injury to superior vena cava, right atrium, or right ventricle
  • Damage to the tricuspid and/or pulmonic valves
  • Arrhythmia
  • Hemorrhage
  • Infection/sepsis
  • Pain at insertion site
  • Hematoma at insertion site
  • Venous thrombosis
  • Vessel perforation
  • Endocarditis

• Product codes: QD22, QD25
• Indications: Indicated for patients undergoing cardiopulmonary bypass to drain non-oxygenated blood from the vena cavae and/or right atrium
• Contraindications: This device should not be used when any medical, anatomical or physiological impairment would contraindicate the use of a femoral venous cannula or cardiopulmonary bypass
• Complications: Possible complications include those normally associated with cardiopulmonary bypass, anticoagulation and large bore venous and arterial cannulation