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ULTIMA OPCAB System

ULTIMA OPCAB System

Ultima OPCAB

ULTIMA OPCAB System

Designed with a rigid arm to offer a unique approach to mechanical tissue stabilization.

Questions? Ask us about ULTIMA OPCAB System

Overview

The ULTIMA OPCAB System is designed with a rigid arm to offer
a unique approach to mechanical tissue stabilization. The ULTIMA OPCAB System combined with XPOSE Access Devices (XPOSE 3 ), forms the ULTIMA Mechanical Off-Pump System. When used together these devices provide a solution for off-pump bypass surgery.

The ULTIMA mechanical stabilizer is equipped with low profile feet, a rigid arm, and quick-lock mount for simple positioning and stabilization of target vessels.

Low-profile, rigid arm design

Multiple degrees of manipulation for easy positioning of stabilizer foot on target artery

2-step positioning

Clinical

Beating Heart Surgery

When a patient is diagnosed with coronary artery disease, a surgeon can perform an operation to restore healthy blood flow to the heart. In this procedure, one or more healthy blood vessels will be taken from the arm, leg or chest and are used to create “new” vessels for the heart.  The surgeon will connect or graft one end of the harvested vessel to the aorta that supplies the blood to the heart; the other end will be attached at the surface of the heart, bypassing the blocked portion of the coronary artery.  It is not uncommon for a surgeon to perform three or four of these grafts during one operation.

Today many people that have medical conditions such as diabetes, history of stroke, or poor physical health can undergo cardiac surgery with an off pump approach that may lower their risk for developing complications. In contrast to conventional bypass surgery, which stops the heart and puts the patient on a heart-lung machine during the grafting procedure, beating heart bypass surgery uses local stabilization of the heart that allows the surgeon to sew the bypass graft while the heart still beats.

The potential benefits of beating heart surgery may include1:
  • Reduced incidence of a common irregular rhythm post-operatively (A-fib)
  • Fewer cognitive and neurological effects (for example, a stroke)
  • Lower incidence of post-operative respiratory failure
  • Faster recovery rates
  • Shorter hospital stays
  • Fewer wound complications
  • Fewer blood transfusions needed

[1] Puskas J, Cheng D, Knight J, et al.  Off-pump versus conventional coronary artery bypass grafting.  A meta-analysis and consensus statement from the 2004 ISMICS Consensus Conference.  Innovations.  2005; 1:3-27

Instructions for use

Prescriptive Information

Prior to use please see the complete 'Instructions 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.

Indications

The ULTIMA OPCAB System is intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The AccessRail Platform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stabilizer isolates and provides local immobilization of the target vessel on the beating heart.

Warnings and Precautions

Physicians should be properly trained to perform cardiac surgical procedures with Maquet instruments prior to use. As with all surgical retractors, care should be taken to use only as much retraction as necessary to provide adequate access and visualization. Perform the anastomosis only when the stabilizer foot is properly seated on the epicardium and adequate stabilization of the surgical site is achieved and do not adjust or open the platform with the stabilizer foot positioned on the epicardium. When removing the ULTIMA Stabilizer from the epicardium, care should be taken not to disrupt the anastomosed site.

Take care not to adjust or move the AccessRail Platform while pericardial sutures are engaged in the platform. Suture holder features are designed for "0" size sutures. The Activator and Activator II Drive Mechanism is supplied non-sterile and must be cleaned and sterilized prior to each use. Never use saline solution for cleaning surgical instruments. Steam sterilization is recommended to sterilize the Activator and Activator II Drive Mechanism. Other methods of sterilization have not been demonstrated as effective and are not recommended.

Downloads

All references

  1. Puskas J, Martin J, Cheng D, et al. ISMICS Consensus Conference and Statements of Randomized Controlled Trials of Off-Pump versus Conventional Coronary Artery Bypass Surgery. Innovations: 2015;10:219-229.

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