The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System incorporates design improvements inspired by the hands-on experience of VASOVIEW 6 users who performed vessel harvesting every day.

The integrated system tools provide improved efficiency and ergonomics for high quality conduit harvesting of the saphenous vein and radial artery. The familiar technology within this system allows for proximal and distal CO2 insufflation and includes a BiSECTORTM Bipolar Ligating Forceps tip for highly hemostatic cauterization.

With improved handle controls and better organization of cables to eliminate wrapping or tangling, the streamlined design is easy to use and may help to shorten the learning curve as well as duration of patient procedure as compared to the VASOVIEW 6 system.*

BiSECTOR Bipolar Ligating Forceps is a trademark of Gyrus Group PLC.

* Data on file.

  • Simplified and larger BiSECTOR rotating carriage, as well as a larger-profile cutting toggle and C-Ring slider - Designed to facilitate easy operation
  • Original, streamlined dissection tip - Designed for ease of dissection, improved tunnel creation, and optimum clarity
  • BiSECTORTM bipolar ligating forceps - Designed to provide highly hemostatic cauterization, increased extension, and full 360º rotation for superior flexibility and maneuverability
  • CO2 insufflation - Designed to create clear, long tunnel views, using innovative focal distal insufflation for further-reaching visualization
  • Intuitive handle design - Built in ergonomically designed controls are easy to use and provide excellent maneuverability
  • Simplified attachment system - Cables consolidated into single bundle

Endoscopic Vessel Harvesting with VASOVIEW can improve patient outcomes due to:

  • A less-invasive 2 cm (1 inch) incision
  • Significantly less risk of infection and wound complications 1
  • More rapid recovery and far less postoperative pain 1
  • Minimal scarring for improved cosmesis 1
  • Efficient harvest of either saphenous vein or radial artery 1

BiSECTOR is a trademark of Gyrus Group PLC.

[1] Allen K, Cheng D, Cohn W, et al.  Endoscopic Vascular Harvest in coronary artery bypass graft surgery:  A consensus statement of the International Society of Minimally Invasive Cardiothoracic Surgery 2005.  Innovations. 2005; 1:51-60.

EVH Procedure

EVH stands for Endoscopic Vessel Harvesting.  During a Coronary Bypass procedure, one or more healthy blood vessels will be taken (or “harvested”) from the patient’s leg, arm or chest to use as “new” vessels for bypass grafts.

There are three techniques for harvesting a vessel for a CABG procedure: open, bridging and EVH. EVH uses special instruments to view and remove a blood vessel with much less trauma to the vessel itself or to surrounding tissues than bridging or an “open” procedure.

In the past, one long incision was made from the ankle to the groin; this procedure is called an open procedure. It is highly invasive, often caused patients more pain than their chest incision, and resulted in a long scar.

An alternative, less invasive technique to the open procedure is called “bridging”. Bridging enables harvesters to gain access to the saphenous vein through three or four smaller incisions of about three inches.

EVH is minimally invasive and uses special instruments to view and remove the blood vessel. EVH usually only requires one small incision about one inch long.  The EVH procedure is performed immediately before heart surgery and can be used for the following vessels:

  • The greater saphenous vein, which runs the length of the leg
  • The radial artery, which runs from the wrist to the elbow in the arm

There is generally little patient discomfort from endoscopic vessel harvesting, especially when compared to open or bridging procedures.  In clinical studies, some important benefits have been shown in EVH including:

  • Significantly less risk of infection and wound complications
  • Less postoperative pain and swelling
  • Faster recovery with minimal scarring
  • Greater patient satisfaction

Instructions for Use

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

VASOVIEW 6 PRO Harvesting Cannula

Important: The following information is designed to assist in the use of the VASOVIEW Harvesting Cannula. It is not a reference to endoscopic surgery or techniques.

Indications

The VASOVIEW 6 PRO System is indicated for use in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels of the extremities, dissection of ducts and other structures in the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Contraindications

VASOVIEW 6 PRO Harvesting Cannula is contraindicated in situations where minimally invasive surgery is contraindicated.

Warnings and Precautions

  • Single Use Only.  Do not re-sterilize.  Single use medical devices can have extremely small and/or structurally complex components. It can be difficult to remove blood, tissue, body fluids and pathogens from the device. In addition, the cleaning and re-sterilization process may compromise the materials and functionality of the device.
  • Read all instructions carefully. Failure to properly follow the instructions, warnings and precautions may lead to serious surgical consequences or serious injury to the patient.
  • Minimally invasive surgical procedures should be performed only by individuals adequately trained and familiar with such surgical techniques. Consult medical literature regarding techniques, complications, and hazards prior to performance of these procedures.
  • Sterility: The product is sterile unless the package is damaged or opened. The product is designed for single use. Do not reuse or resterilize. The method of sterilization is irradiation.
  • Before endoscopic instruments and accessories from different manufacturers are employed in a procedure, verify compatibility and ensure that electrical isolation and grounding of these instruments is not compromised.
  • A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both the patient and operator(s) and damage to medical instrumentation.
  • The VASOVIEW 6 PRO Endoscopic Vessel Harvesting System is for use with the bipolar outputs of electrosurgical generators only!
  • FOR INTERMITTENT OPERATION ONLY: Do not apply continuous cautery energy.
  • Do not exceed 30 watts in any mode.
  • Use generators listed in the specified Mode and Setting Range only.
  • Do not use with Codman Malis generators.
  • All exposed metal components at the distal end of the bisector may coagulate tissue. Ensure all exposed metal is within the field of vision and contacting the tissue intended for coagulation during the application of electrosurgical energy.
  • Handle the Endoscope carefully to avoid breakage. Regularly check the orientation of the camera before advancing.
  • To avoid damage to delicate tissue, advance the cannula gently.
  • Always advance the C-Ring and Bipolar Bisector under endoscopic visualization. Ensure adequate visualization of Bipolar Bisector ends and surgical site prior to application of electrosurgical energy.
  • Always inspect the surgical site for hemostasis. If hemostasis is not present, appropriate techniques should be applied to achieve hemostasis.
  • In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare (approximately 1 in 10,000 cases) but potentially serious complication that may occur. Its occurrence is signaled by cardiovascular collapse (sudden, severe hypotension) and a precordial murmur. If gas embolism is suspected during a procedure, discontinue gas insufflation and place the patient in a left lateral and a slight Trendelenburg position.
  • When performing radial artery harvesting, the radial artery harvesting procedure should be performed prior to placing the patient on cardiopulmonary bypass.
  • Do not touch the coagulating surfaces while the device is activated. This may cause injury.
  • The cables to the device should be positioned in such a way that contact with the patient or other leads is avoided. Temporarily unused product should be stored in a location that is isolated from the patient.
  • The use of flammable anesthetics or oxidizing gases such as nitrous oxide and oxygen should be avoided if a surgical procedure is carried out in the region of the thorax, unless these agents are sucked away.
  • Non-flammable agents should be used for cleaning and disinfection wherever possible. Flammable agents used for cleaning or disinfecting, or as solvents of adhesives, should be allowed to evaporate before the application of high frequency surgery. There is a risk of pooling of flammable solutions under the patient or in body depressions. Any pooled fluid should be mopped up before high frequency surgical equipment is used.
  • Attention should be called to the danger of ignition of endogenous gases. Some materials, for example cotton, wool, and gauze, when saturated with oxygen may be ignited by sparks produced in normal use of the high frequency surgical equipment.
  • Interference produced by the operation of high frequency surgical equipment may adversely influence the operation of other electronic equipment.
  • Regularly inspect surgical accessories, particularly the bipolar cables, for any possible damage or unintended rough surfaces, sharp edges, or protrusions.
  • Prior to use of the device in patients who have cardiac pacemakers or electronic implants, consult the implant manufacturer’s instructions.
  • Use caution when the target anatomy to be placed between the electrodes of the Bisector is located close to the skin surface as this situation may cause thermal injury to the skin surface and related structures.

7 mm Extended Length Endoscope and Dissection Tip

Indications

The 7 mm Extended Length Endoscope with Dissection Tip is indicated for visualization of a surgical cavity and dissection in endoscopic procedures and other minimally invasive surgical procedures allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients requiring endoscopic tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

Contraindications

The device is contraindicated in situations where endoscopic techniques and minimally invasive surgery are contraindicated.

Warnings and Precautions

  • Read all instructions carefully. Failure to properly follow the instructions, warnings and cautions may lead to serious surgical consequences or serious injury to the patient.
  • Endoscopic procedures should be performed only by physicians or surgical professionals having adequate training and familiarity with endoscopic techniques. Consult medical literature regarding techniques, complications, and hazards prior to performance of these procedures.
  • The Endoscope is a reusable instrument that is supplied non-sterile. Thoroughly clean and sterilize the Endoscope prior to each use. Follow recommended cleaning and sterilization instructions as described in the Instructions for Use.
  • The Endoscope is a fragile instrument. Handle carefully to avoid breakage; bending of the shaft or dropping the Endoscope may damage the optics or other internal components, making the Endoscope inoperable. Sterilize and store in a protective tray whenever possible.
  • The Dissection Tip is sterile unless the package is opened or damaged. The Tip is designed for single use. Do not reuse or resterilize the Dissection Tip.
  • Whenever using endoscopic illumination equipment, ensure that the light cable connectors never rest on flammable materials such as surgical drapes, towels, etc.
  • Always inspect the surgical site for hemostasis. If hemostasis is not present, appropriate techniques should be applied to achieve hemostasis.
  • In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare but potentially serious complication that may occur (in approximately 1 in 10,000 cases). Its occurrence is signaled by cardiovascular collapse (sudden, severe hypotension), and a precordial murmur. If gas embolism is suspected during a procedure, discontinue gas insufflation and place the patient in a left lateral and a slight Trendelenburg position.
  • If Prevacuum or Gravity steam sterilization (autoclave) are used, the Endoscope may have a shorter life due to harsher sterilization environment. Inspect the Endoscope after each steam sterilization cycle for damage.
  • Do not cool a hot Endoscope after sterilization by rapidly exposing it to air or liquid. Sudden temperature changes may cause glass components to crack.
  • Do not "flash" steam sterilize (autoclave) the Endoscope. Flash (i.e., unwrapped) steam sterilization cycles introduce sudden temperature changes, which may cause glass components to crack.
  • Sterilization with liquid chemical sterilants (e.g., STERIS) may not convey the same sterility assurance as other sterilization methods.

Short Port BTT

Caution: This product contains natural rubber latex which may cause allergic reactions. Important: The following information is designed to assist in the use of the Short Port Blunt Tip Trocar (BTT). It is not a reference to endoscopic surgery or techniques.

Indications

This product has applications for surgery in the saphenous vein and radial artery for establishment of a port of entry for endoscopic instruments.

Contraindications

The device is contraindicated in situations in which minimally invasive surgery is contraindicated.

Warnings and Precautions

  • Read all instructions carefully. Failure to properly follow the instructions, warnings, and cautions may lead to serious surgical consequences or serious injury to the patient.
  • Minimally invasive surgical procedures should be performed only by individuals adequately trained and familiar with such surgical techniques. Consult medical literature regarding techniques, complications, and hazards prior to performance of these procedures.
  • Sterility: The product is sterile unless the package is damaged or opened. The product is design for single use. Do not reuse or resterilize. The method of sterilization is irradiation.
  • Before endoscopic instruments and accessories from different manufacturers are employed in a procedure, verify compatibility and ensure that electrical isolation and grounding of these instruments are not compromised.
  • A thorough understanding of the principles and techniques involved in electrosurgical procedures is essential to avoid shock and burn hazards to both the patient and operator(s) as well as damage to medical instrumentation.
  • Balloon products must be treated with care. Damage to balloons by instruments used during insertion and in the course of a procedure may result in balloon rupture.
  • The balloon on the Short Port Blunt Tip Trocar contains a fully coated natural rubber latex and may affect patients with latex sensitivities if the coating becomes damaged.
  • Overinflation of the BTT Port balloon may result in balloon rupture. Do not inflate with more than 25 cc of air. 9) In endoscopic procedures which use gas insufflation, venous gas embolism is a very rare (approximately 1 in 10,000 cases) but potentially serious complication that may occur. Its occurrence is signaled by cardiovascular collapse (sudden, severe hypotension) and a precordial murmur. If gas embolism is suspected during a procedure, discontinue gas insufflation and place the patient in a left lateral and a slight Trendelenburg position.

VASOSHIELD Pressure Controlling Syringe

Indications

The device is indicated for controlling pressure during the preparation and irrigation of blood vessels prior to use as a bypass graft.

Contraindications

There are no known contraindications to the use of the device.

Warnings and Precautions

  • Contents sterile only if protective package is not opened, damaged or broken.
  • Avoid excessive, rapid compression of the plunger during use as it may cause a transient high pressure period.
  • Do not reuse or resterilize. Dispose of the device after use per standard hospital procedure.
  • The VASOSHIELD syringe must not be employed for forceful irrigation of arterial conduits to reverse spasm.
  • For routine use during vessel preparation and irrigation, always use the lowest setting possible.

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How to order

To place an order or learn more about any of the Maquet products, related accessories, or therapeutic solutions, please contact your local sales representative. 

EVH: Can you afford not to?

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