Cardioblate® CryoFlex™ Unique malleability delivers argon-powered cryoablation to create reproducible, transmural lesions with a single probe.

Surgical Ablation System

Shaping Surgical AF Ablation.

Cardioblate® Surgical Ablation Systems have been designed with maneuverability, placement and visualization in mind. Uniquely malleable devices put surgeons in control of creating the Maze III lesion set with superior energy sources that give greater confidence of lesion transmurality.

Designed for easy access.

Cardioblate® CryoFlex™ Surgical Ablation Probe

Cardioblate® Surgical Ablation Portfolio

Argon Freezes to Lethal Cell Temperatures Deeper and Faster4

20 40 60 80 100 120

Argon vs. Nitrous Oxide

Bench test comparison between Cardioblate® CryoFlex™ probe and AtriCure Cryo 1™ probe on 7 mm thick porcine tissue. Simultaneous freezes with both devices were performed upon tissue, while recording temperatures on the tissue surface opposite of the probes.

Freeze Time(s)

Opp

osite

-Sid

e Ti

ssue

Tem

p. (º

C)

Argon Nitrous Oxide Results may not be indicative of clinical performance.

Lethal Cell Temperature

30

20

10

0

-10

-20

-30

-40

-50

Levels of Cell Death5,6,7,8

Necrosis [≈ -20˚C – -40˚C and colder] Cell destruction is immediate and irreversible.

Apoptosis [≈ 0˚C – -20˚C ] Cells are damaged and may recover; some cells destroyed

Hypothermia [≈ 32˚C – 0˚C ] Cells temporarily stop functioning

Effective Cryoablation Achieves Necrotic Cell Temperatures Through Targeted Tissue

Cross Section of Tissue

Probe Tip

Freeze deeper and faster for transmurality.• The Cardioblate® CryoFlex™ Argon-powered Cryoablation System puts surgeons in control

of Maze III surgical atrial fibrillation (AF) procedures

• Uniquely hand-malleable devices enhance maneuverability, placement and visualization for easier ablation around pulmonary veins and upon atrial tissue

• Use CryoFlex probes on an arrested heart via sternotomy or right thoracotomy

• Compared to dry radiofrequency, the CryoFlex system provides added safety around vulnerable tissue structures1,2

• Complete the entire Maze III lesion set with a single CryoFlex probe

Advantage Argon.• Argon is the coldest commercially available surgical AF ablation energy source

• CryoFlex probes reach approximately -150ºC in test freezes3

• In vitro tests show argon-powered cryoablation achieved deeper lesions than those formed by nitrous oxide cryoablation4

Cardioblate® CryoFlex™

Cardioblate® CryoFlex™

Surgical Ablation Probes

Adjustable Insulation Sheath. Varies the length of the exposed probe tip and helps protect non-targeted tissue.

Hand Malleable. Quickly shape and re-shape by hand to facilitate placement.

Distinctly malleable.

Hand-malleable probes for every Maze III lesion.

• Corrugated probes are easily shaped and re-shaped multiple times

• Use via sternotomy or right thoracotomy

• Intuitive one-piece attachment to the CryoFlex generator console

• 7cm, 10cm and 10-S probes to satisfy procedural preference

• 10-S probe optimizes malleability and increased shape retention to provide greater tissue apposition

Cardioblate® CryoFlex™

Surgical Ablation Console

Cardioblate® CryoFlex™

Surgical Ablation Clamp and Probe

• Quick and easy to set up for use

• Intuitive one-touch push-button controls

The convenience of a clamp and probe in a single device.

• Combine the versatility of the CryoFlex 10cm probe with the familiar and useful delivery of a clamp

• Parallel closing jaws feature a viewing window for visualization of frost penetration through tissue

• Eject the probe to complete all lesions in the Maze III surgical ablation procedure

• Use via sternotomy

2-in-1 Device. Remove the probe from the clamp to complete all lesions in the Maze III procedure.

Visual Confirmation. A unique viewing window in the proximal jaw of the clamp

allows visualization of frost coming completely through the tissue.

Wide-opening Jaws. Aid clamp placement around pulmonary veins and upon atrial tissue.

Single-trigger Mechanism. Enables easy clamp and release.

Cardioblate® Surgical Ablation Portfolio

Product Ordering Information

The Cardioblate CryoFlex Surgical Ablation SystemIndications for Use: is intended for minimally invasive cardiac surgical procedures, including the treatment of cardiac arrhythmias. The Cardioblate CryoFlex 7 cm, 10 cm, 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 Events or Complications: 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); 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.

For a complete listing of all indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.

Cardioblate is a registered trademark of Medtronic, Inc. CryoFlex is a trademark of Medtronic, Inc. AtriCure Cryo 1 is a trademark of AtriCure, Inc.

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World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA Tel: (763) 514-4000 Fax: (763) 514-4879

Medtronic USA, Inc. Toll-free: 1 (800) 328-2518 (24-hour technical support for physicians and medical professionals)

Europe Medtronic International Trading Sàrl Route du Molliau 31 Case postale 84 CH-1131 Tolochenaz Switzerland Tel: 41.21.802.7000 Fax: 41.21.802.7900

Canada Medtronic of Canada Ltd. 99 Hereford Street Brampton, Ontario L6Y 0R3 Canada Tel: (905) 460-3800 Fax: (905) 826-6620 Toll-free: 1 (800) 268-5346

Asia Medtronic International Ltd.Suite 1106-11, 11/F, Tower 1,The Gateway, 25 Canton Road,Tsimshatsui, Kowloon,Hong KongTel: +852 2919-1362Fax: +852 2907-3998E-mail: enquiryap@medtronic.com

Latin America Medtronic USA, Inc. Doral Corporate Center II 3750 NW 87th Avenue Suite 700 Miami, FL 33178 USA Tel: (305) 500-9328 Fax: (786) 709-4244

LifeLine CardioVascular Technical Support Tel: (877) 526-7890 Tel: (763) 526-7890 Fax: (763) 526-7888 E-mail: rs.cstechsupport@medtronic.com

www.medtronic.com

References1. FrostByte Chronic Dosing Study Summary Report. Data on file. MO61 Rev-0 August 2005. CryoCath Technologies Inc. Montreal, Canada.2. Khairy P, Chauvet P, Lehmann J, et al. Lower incidence of thrombus formation with cryoenergy versus radio frequency catheter ablation. Circulation 2003;107:2045-50. 3. Medtronic Data on File. 4. Medtronic in vitro test data on file. Bench test comparison of the performance of Cardioblate CryoFlex argon-powered probe to AtriCure Cryo 1 nitrous oxide-powered probe on porcine tissue.

Results may not be indicative of clinical performance.5. Baust JG, Gage AA. The molecular basis of cryosurgery. Institute of Biomedical Technology, State University of New York, Binghamton, and School of Medicine and Biomedical Sciences, State

University of New York at Buffalo, Buffalo, New York, NY, USA; pp.1187-91.6. Gage A, Baust JM, Baust JG. Experimental cryosurgery investigations in vivo. Journal of Society for Cryobiology 2009. Vol 59: 3; 229–43.7. Aoyama H, Nakagawa H, Pitha J, et al. Comparison of cryothermia and radiofrequency current in safety and efficacy of catheter ablation within the canine coronary sinus close to the left

circumflex coronary artery. J Cardiovasc Electrophysiol 2005: Vol. 16;1218-26.8. Gage AA, Baust J. Review Mechanisms of Tissue Injury in Cryosurgery. Cryobiology Vol. 37; pp. 171-86. State University of New York, Binghamtom, NY. ©1998 Academic Press.

CryoFlex™ Single-Use Probes

PRODUCT CATALOG CODE NO. USE

CryoFlex™ Probe, 7 cm 60SF7 1 each SingleCryoFlex™ Probe, 10 cm 60SF2 1 each SingleCryoFlex™ 10-S Probe, 10 cm 60SF3 1 each SingleCryoFlex™ Clamp and Probe, 10 cm 60CM1 1 each Single

Note: The Cardioblate® CryoFlex™ Argon-Powered Surgical Ablation System uses argon refrigerant for rapid ablation. Argon gas tanks are obtained and refilled by local gas suppliers of the hospital’s choice. For more information, call 877-526-7890 or 763-526-7890.

CryoFlex™ Console Components

PRODUCT CATALOG CODE NO. USE

CryoFlex™ Control Panel 65CS1 1 each ReusablePower Cord; CryoFlex™ Control Panel:*• North American Standard 671PCNA 1 each Reusable• European Standard 671PCE 1 each Reusable• Italian Standard 671PCY 1 each Reusable• United Kingdom Standard 671PCUK 1 each ReusableCryoFlex™ Regulator (with pressure sensor cable):*• North American Standard 67RAXNA 1 each Reusable• European Standard 67RAXE 1 each ReusableGas Hose; CryoFlex™ System 67H08 1 each ReusablePressure Sensor Cable; CryoFlex™ System 67PS6 1 each Reusable (replacement only)CryoFlex™ Tank Carrier 65TC1 1 each Reusable

* Order one per local standard.