Putting the future in your hands today.

Transcription

1 Putting the future in your hands today. Minimally Invasive Cardiac Surgery thinking forward

2 Minimally Invasive Cardiac Surgery (MICS) starts with thinking forward Minimally invasive procedures present new opportunities to reduce trauma and impact to patients being treated for cardiovascular disease. As the world s largest medical device company, Medtronic strives to provide the resources needed to facilitate the evolution of cardiac surgery toward the least invasive, most effective treatment possible. We re committed to providing access to the broadest portfolio of therapy, technology and training resources to help you transition from arrested, open chest procedures to less invasive procedures patients are requesting today. moving forward to provide advanced options for you and your patients. MICS CABG Heart Valve Surgery Surgical Ablation Perfusion Techniques for Blood Conservation

3 innovating forward with the most comprehensive MICS CABG minimally invasive CABG products and training Minimally invasive coronary artery bypass graft (CABG) surgery is a beating heart multi-vessel procedure in which the anastomoses are performed under direct vision through a lateral mini-thoracotomy. MICS CABG is a versatile procedure in which a hybrid or pump-assisted beating heart approach can be employed to meet your preference. Not all patients are candidates for beating heart procedures. Some patients would require cardiopulmonary support during surgery. Potential benefits of MICS CABG include reduced hospital stay, faster recovery, improved cosmetic outcome, and greater patient satisfaction. 1, 2 Caution: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures. ThoraTrak MICS Retractor System Starfish NS Heart Positioner Octopus Nuvo Tissue Stabilizer Bio-Medicus Femoral Cannulae

4 evolving forward with 35 years of experience to deliver Heart Valve Surgery more innovative options to help you treat valve disease Minimally invasive valve surgery is characterized by a small incision, usually performed as a right mini-thoracotomy or a mini-sternotomy under direct vision. Access and visibility are facilitated using femoral arterial and venous cannulation and minimized cardiopulmonary bypass support with augmented venous return techniques. Not all patients are candidates for minimally invasive heart valve surgery. These products have unique indications, warnings, and precautions. Refer to individual components for specific information. Devices are not intended for use except as indicated. Caution: Care and caution should be taken to avoid damage to vessels and cardiac tissue during cannulation or other cardiac surgical procedures. The most recognized benefit of minimally invasive valve surgery is a better cosmetic result. Other potential benefits are reduced trauma and pain, decreased blood loss, decreased wound infection, 3 and reduced recovery time. 3, 4 Freestyle Heart Valve Mosaic & Mosaic ULTRA Heart Valves with Cinch Holder Profile 3D Ring CG Future COMPOSITE Ring and CG Future Band Duran AnCore Ring and Band Simplici-T Band MiAR Antegrade Cardioplegia Cannulae MiRCSP Retrograde Cardioplegia Cannulae

5 driving forward with confidence Surgical Ablation you ll achieve consistent conduction block in your next MICS ablation case 5 Minimally invasive ablation surgery is characterized by two small incisions (right and left mini-thoracotomies) and two small port-sized incisions per side. Therapy is similar to a sternotomy-based approach, but access and visibility are different. The Cardioblate Surgical Ablation Device should not be used for patients who have active endocarditis at 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 Conduction disturbances (SA/AV node) Acute ischemic myocardial event Thrombus formation Direct vision is supported by endoscopic visualization and is the recommended technique for surgeons learning to perform minimally invasive ablation procedures. As surgeons gain more experience, they may choose to reduce the incision size and move to a completely thoracoscopic approach. Cardioblate Gemini -s Surgical Ablation Device Cardioblate Gemini -x Surgical Ablation Device Cardioblate Navigator Tissue Dissector Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device

6 staying forward with perfusion options that reduce trauma Perfusion Techniques for Blood Conservation and impact for your CABG and valve surgery patients Rethinking Blood Conservation (RBC), an evidence-based educational program offered by Medtronic, works with you to devise strategies and tactics to improve cardiac procedures, including MICS. Important aspects of RBC include use of a centrifugal pump incorporated into a minimized cardiopulmonary bypass circuit with a biocompatible coating, femoral arterial and venous cannulation using augmented venous return techniques, and a comprehensive blood conservation strategy. We provide a multi-modality approach to blood conservation that incorporates reduced-prime and biocompatible extracorporeal circuits, autologous bloodcell salvaging, and hemostasis management. Through various product selections, techniques and procedures, studies have shown a reduction in post-op complication rates 6 and reduced transfusion requirements both intra- and post-operatively. 6, 7 Cannulation techniques for minimally invasive procedures are dependent on the incision and access site as well as surgeon preference. We offer many cannulae to facilitate femoral and direct cannulation of vessels through both open and percutaneous insertion methods.

7 moving forward with convenient access to Advance Your Technique With Training world class training Through Medtronic CardioVascular Academia programs, we offer unique training involving the latest technologies and advanced techniques in minimally invasive cardiac surgery. Come and learn the skills that will place your practice at the leading edge of cardiac surgery. During a typical session, you can expect to: Observe procedures performed by leading surgeons. Gain knowledge of patient selection, key procedural steps, instrumentation, anesthesia management and post-surgical care. Interact with surgical teams and discuss protocol changes to achieve the greatest benefits from the procedure. Visit for a listing of our most â current training locations.

8 MICS CABG ThoraTrak MICS Retractor System Octopus Nuvo Tissue Stabilizer Starfish NS Heart Positioner Bio-Medicus Femoral Cannulae Heart Valve Surgery Mosaic & Mosaic ULTRA Heart Valves with Cinch Holder Freestyle Heart Valve CG Future COMPOSITE Ring and CG Future Band Cannulae Duran AnCore Ring and Band Profile 3D Ring Simplici-T Band Bio-Medicus Femoral Access Arterial and Venous Cannulae MīAR Antegrade Cardioplegia Cannulae MiRCSP Retrograde Cardioplegia Cannulae MiRCSP Cannulae Fehling Instruments* long and medium handled surgical instruments Cardioblate Gemini -s Surgical Ablation Device Cardioblate Gemini -x Surgical Ablation Device Surgical Ablation Cardioblate Navigator Tissue Dissector Cardioblate MAPS Mapping, Ablation, Pacing and Sensing Device * Medtronic, Inc. is an authorized distributor of these products. References 1. McGinn JT, Usman S, Lapierre H, Pothula VR, Mesana TG, Ruel M. Minimally invasive coronary artery bypass grafting: dual center experience in 450 consecutive patients. Circulation. 2009; 120:S78-S Poston RS, Tran R, Collins M, et al. Comparison of Economic and Patient Outcomes With Minimally Invasive Versus Traditional Off-Pump Coronary Artery Bypass Grafting Techniques. Ann Surg 2008;248: Liu J, Sidiropoulos A, Konertz W. Minimally invasive aortic valve replacement (AVR) compared to standard AVR. Eur J Cardiothorac Surg. 1999;S Sharony R, Grossi E, Saunders P, et al. Minimally invasive aortic valve surgery in the elderly: a case control study. Circulation. 2003;108[suppl 11]: Premarket Notification (510(k)), K080509, Section , May 5, Food and Drug Administration (FDA) Center for Devices and Radiological Health. 6. Ranucci M, Isgrò G. Minimally invasive cardiopulmonary bypass: Does it really change the outcome? Critical Care 2007; 11:R Harostock M 3rd, Filler JJ, Burak DA, et al. Comparison of transfusion requirements for conventional and miniaturized extracorporeal circuits. Heart Surg Forum. 2008;11(3):E Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use provided with each product. Bio-Medicus Cannulae 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 Gemini Surgical Ablation Device Indications: The Cardioblate Gemini Surgical Ablation Device is intended to ablate cardiac tissue during cardiac surgery using radiofrequency energy. 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 (e.g., through a purse string suture on a beating heart). Effects of this type of ablation are unknown. Freestyle Aortic Root Bioprosthesis Indications: For the replacement of malfunctioning native or prosthetic aortic valves with the option of aortic root replacement. 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 w ith altered calcium metabolism (e.g., chronic renal failure, hyperparathyroidism). Adverse events can include: cardiac dysrhythmias, death, endocarditis, hemolysis, hemorrhage, transvalvular or paravalvular leak, nonstructural dysfunction, structural deterioration, thromboembolism, valve thrombosis, or intracuspal hematoma. MiAR Cannulae Indications: For use during cardiopulmonary bypass for the delivery of cardioplegia for up to 6 hours. The cannula may also be used to aspirate air from the aorta at the conclusion of the bypass procedure. It is indicated for use during cardiac surgery for median sternotomy or minimally invasive (mini-sternotomy or right thoracotomy) access using direct visualization techniques. Contradictions: This device is not intended for use except as indicated. 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. MiRCSP Cannulae 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. Trademarks may be registered and are the property of their respective owners. World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN USA Tel: (763) Fax: (763) Medtronic USA, Inc. Toll-free: 1 (800) (24-hour technical support for physicians and medical professionals) LifeLine CardioVascular Technical Support Tel: (877) Tel: (763) Fax: (763) rs.cstechsupport@medtronic.com UC c EN 2012 Medtronic, Inc.