International Only - Not intended for physicians in the U. S. or Japan

Indications, Safety and Warnings

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.

Bio-Medicus® Cannula

Indications: This percutaneous cannula is for use by trained physicians only, to cannulate vessels, perfuse vessels or organs in a patient for cardiopulmonary bypass circulation. Standard surgical or percutaneous insertion techniques can be employed. This product is intended for use up to six hours or less.

Contraindications: Alone, this cannula is not a medical treatment device. Selection of patient as a candidate for such procedures is the physicians’ responsibility. The outcome is dependent on many variables including patient pathology, surgical procedure, and perfusion procedures. Do not use if the patient has severe peripheral atherosclerosis or severe arterial dissection. This device is not intended for use except as indicated.

Cardioblate® CryoFlex™ Surgical Ablation Probe

Indications: The Cardioblate CryoFlex Surgical Ablation System is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7cm, 10cm, and 10-S probes plus the Cardioblate CryoFlex Clamp and Cardioblate CryoFlex Surgical Ablation Console freeze target tissue and block the electrical conduction pathways by creating an inflammatory response and cryonecrosis.

Contraindications: The Cardioblate CryoFlex Surgical Ablation Probe is not designed for use inside a beating heart.

Adverse Effects: Potential adverse events with this device are similar to other cardiac surgery procedures and may include the following: bleeding; re-operation; extension of extracorporeal bypass; heart rhythm disturbances (atrial and/or ventricular); pericardial effusion; pericarditis; cardiac tamponade; pleural effusion; mediastinitis; conduction disturbances (SA/AV node); acute ischemic myocardial event; thrombus formation; low cardiac output; stroke; renal, gastrointestinal or respiratory complications; sepsis; adjacent structural damage; and death.

  • Avoid contact between the cryoablation probe and the phrenic nerve to avoid injury. Perioperative heart rhythm disturbances (atrial and/or ventricular)

Cryoablation involving coronary vessels has been associated with subsequent clinically significant arterial stenosis. It is unknown whether Cryoablation with the Cardioblate CryoFlex Surgical Ablation Probe will have such an effect, but as in all such procedures, care should be taken to minimize unnecessary contact with coronary vessels during Cryoablation.

Cardioblate Detect Surgical Pacing and Mapping Tool

Indications: The Cardioblate Detect Surgical Pacing and Mapping Tool is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy.

Contraindications: The Cardioblate Detect Surgical Pacing and Mapping Tool should not be used for:

  • Patients that have active endocarditis at the time of surgery

Potential Complications: Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are:

  • Tissue perforation
  • Extension of Extracorporeal bypass
  • Perioperative heart rhythm disturbances (atrial and/or ventricular)
  • Postoperative embolic complications
  • Pericardial effusion or tamponade
  • Injury to the great vessels
  • Valve leaflet damage
  • Conductions disturbances (SA/AV node)
  • Acute ischemic myocardial event

Cardioblate® Gemini® Surgical Ablation Device

Indications: The Cardioblate Gemini Surgical Ablation Device is intended to create lesions in cardiac tissue during a minimally invasive or closed-chest procedure using radiofrequency energy for the treatment of cardiac arrhythmias. The system is indicated for use under direct or endoscopic visualization, in surgical procedures, including minimally invasive surgical procedures.

Contraindications:The Cardioblate Gemini Surgical Ablation Device should not be used for:

  • Patients that have active endocarditis at the time of surgery
  • Ablation in a pool of blood (eg, through a purse string suture on a beating heart). Effects of this type of ablation are unknown.

Adverse Effects: Possible complications related to the ablation of cardiac tissue in combination with open heart surgery are: tissue perforation, extension of extracorporeal bypass, perioperative heart rhythm disturbances (atrial and/or ventricular), postoperative embolic complications, pericardial effusion or tamponade, injury to the great vessels, valve leaflet damage, Conduction disturbances (SA/AV node), acute ischemic myocardial event, thrombus formation, nerve damage, unintentional burns, pericarditis, pleural effusion.

Cardioblate® MAPS Mapping, Ablation, Pacing, and Sensing Device

Indications: The Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. The Cardioblate® MAPS Surgical Mapping, Ablation, Pacing, and Sensing Device is intended to ablate cardiac tissue using radiofrequency energy for the treatment of cardiac arrhythmias when connected to the Cardioblate® 68000 generator, or for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to an external temporary pacemaker.

Contraindications: The Cardioblate MAPS Mapping, Ablation, Pacing, and Sensing Device should not be used for patients that have active endocarditis at the time of surgery.

Adverse Effects: Possible complications related to the use of this instrument in combination with cardiac surgery are: tissue perforation, extension of extracorporeal bypass, perioperative heart rhythm disturbances (atrial and/or ventricular), postoperative embolic complications, pericardial effusion or tamponade, injury to the vessels, valve leaflet damage, conduction disturbances (SA/AV node), acute ischemic myocardial event, thrombus formation, nerve damage, unintentional burns, pericarditis, pleural effusion, esophageal perforation.

Cardioblate® Navigator® Tissue Dissector

Indications: The Cardioblate® Navigator™ Tissue Dissection Device is intended to dissect soft tissue during surgical procedures. The device's battery-powered light source is used to navigate soft tissue for identification of the tip location around anatomic structures.

Potential Complications: Using excessive force when articulating may damage the distal links and/or cause unintended tissue damage.

CG Future® Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Adverse Effects: Adverse events can include thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

Duran AnCore® Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis. Note: The Chordal Guide feature of the Duran AnCore® Ring/Band with Chordal Guide is indicated only for chordal replacement surgery of pathological mitral valves.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Adverse Effects: Adverse events can include thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

MiAR™ Cannula

Indications: The MiAR cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia Antegrade through the Aorta for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques.

Contraindications: This device is not intended for use except as indicated.

Adverse Effects: This device, as do all extracorporeal blood system devices, has possible side effects which include, but are not limited to, infections, blood loss, thrombus formation, embolic events, and dislocation. Vessel damage and complications at the puncture site may occur if the Instructions for Use are not followed.

MiRCSP® Cannula

Indications: The MiRCSP cannula is intended for use during cardiopulmonary bypass for the delivery of cardioplegia retrograde through the coronary sinus for up to six hours. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct, echocardiographic or fluoroscopic visualization techniques.

Contraindications: This device is not intended for use except as indicated above.

Adverse Effects: This device, as do all extracorporeal blood system devices, has possible side effects which include, but are not limited to, infections, blood loss, thrombus formation, embolic events, and dislocation. Vessel damage and complications at the puncture site may occur if the Instructions for Use are not followed.

Mosaic® Porcine Bioprosthesis

Indications: For the replacement of malfunctioning native or prosthetic aortic and/or mitral heart valves.

Contraindications: This device is not intended for use except as indicated.

Warnings/Precautions/Adverse Events: Accelerated deterioration due to calcific degeneration of bioprosthesis may occur in: children, adolescents, young adults, and patients with altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: angina, cardiac arrhythmia, cardiac dysrhythmias, death, endocarditis, heart failure, hemolysis, hemolytic anemia, hemorrhage, transvalvular or paravalvular leak, myocardial infarction, nonstructural dysfunction, stroke, structural deterioration, thromboembolism, or valve thrombosis.

Octopus® NS Tissue Stablizer

Indications: This product is intended to stabilize and minimize the motion of selected areas of the beating heart during cardiac surgery procedures that utilize a thoracotomy of at least 4 cm for access.

Contraindications: This product is not intended for use except as indicated above. Do not position the tissue stabilizers over a coronary artery, newly infarcted or aneurysmal heart tissue.

Adverse Effects: None known.

Octopus® NUVO Tissue Stabilizer

Indications: The product is intended to stabilize and minimize the motion of selected areas of the beating heart during minimally invasive cardiac surgery (MICS) procedures under direct visualization through a thoracotomy.

Contraindications: This product is not intended for use except as indicated above. Do not position the tissue stabilizer over a coronary artery, aneurysm, or newly infarcted heart tissue.

Adverse Effects: None known.

Profile 3D® Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Adverse Effects: Adverse events can include thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

Simplici-T® Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

Adverse Effects: Adverse events can include thromboembolic events, band dehiscence, hemolysis, stenosis, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage, uncorrected or recurrent regurgitation, low cardiac output, thrombosis, or damage to coronary arteries.

Spyder® Anastomotic Device

Indications: The Spyder Anastomotic Device is intended to create anastomoses in blood vessels for use in cardiovascular and coronary artery bypass grafting procedures.

Contraindications: None known.

Starfish NS Heart Positioner

Indications: The Starfish NS Heart Positioner is intended to enable manipulation of the beating heart in cardiac surgery procedures that utilize a thoracotomy of at least 4 cm for access.

Contraindications: This product is not intended for use except as indicated above.

Do not attach device to:

  • Newly infarcted tissue
  • Aneurysmal tissue
  • Directly over a coronary artery
  • Fragile tissue

ThoraTrak® MICS Retractor System

Indications: The Thoratrak MICS Retractor System is intended to provide surgical access for minimally invasive cardiothoracic procedures by retraction of soft and bony tissue.

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