Innovative Heart Stabilization System Experience the New Standard in Precision and Control

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1 FLEXSITE * Heart Stabilizer Innovative Heart Stabilization System Experience the New Standard in Precision and Control Single actuator for easier positioning Malleable feet with full 360 rotation and swivel

2 Only FLEXSITE offers an exclusive, single grip actuator for single motion control FLEXSITE represents a major advance in precision placement and control, allowing the foot and arm to be easily positioned and locked into place. Fast, Precise, Easy-to-Use Flexible stabilizer arm for excellent range of motion and accurate positioning Unique handle design allows a single operator to position the foot and arm in one motion Low profile design provides optimal access and visualization Single spring-grip actuator lets you perform fine positioning adjustments Locks into position with one click of the handle Vacuum or compression feet provide flexible access to all targets Unique handle design Single-hand actuation controls all functions Flexible stabilizer arm for precise positioning Foot options Interchangeable vacuum or compression stabilization feet Disposable suture stays The OPTRAC * Retractor allows you to place the FLEXSITE Stabilizer anywhere along the three rails.

3 FLEXSITE... optimal visualization, optimal access A significant enhancement to the CardioVations PRECISION-OP* System Both vacuum and compression feet are malleable to allow contouring to the epicardial surface Low profile handles, inferior-rail attachment and articulating shaft provide improved angle of sight for superior visualization, for both surgeon and assistant Low profile site specific spreadable suction feet and vacuum tubing allow for greater anastomotic access Offset shaft position provides an unobstructed operative field Optional vacuum foot is designed to provide vacuum assisted compression for optimal stabilization and control. Both compression and vacuum feet are designed to rotate and swivel 360. Vacuum foot is malleable and may be contoured and spread for optimal contact and access.

4 The FLEXSITE Heart Stabilization System gives you the confidence of control, precision, access and visualization One movement of the handle controls retractor attachment, arm alignment, and positioning or exchange of the foot without assistance. Maximum flexibility Stabilizer body attaches securely anywhere along the OPTRAC* Retractor s three rails for optimal access Proprietary arm design maximizes flexibility Malleable suction or compression feet allow custom contouring to conform to epicardial surface Feet rotate and swivel 360 for maximum positioning flexibility One movement provides full function control Positioning on the OPTRAC Retractor Alignment and positioning of the arm to the target Positioning or exchange of the foot 1. Attaching FLEXSITE to the retractor rail: Position the stabilizer body along any one of the three rails of the OPTRAC Retractor. Press the blue button, release the grip, and the FLEXSITE Stabilizer is locked securely into position on the rail. 2. Adjusting the Stabilizer: With one hand, adjust the foot to the target site. A slight squeeze of the handle allows you to make minor positioning tweaks and adjustments. 3. Stabilizing the target area: Release the grip, and the entire FLEXSITE Stabilizer becomes rigid and locked into position and the target area is stabilized.

5 PRECISION-OP *...a complete line of heart stabilization products and accessories for optimal precision ORDERING INFORMATION PRODUCT CODE DESCRIPTION UNITS PER BOX PRODUCT CODE DESCRIPTION UNITS PER BOX FSM FLEXSITE-M 1 (shown with Compression Foot, Left) FSV FLEXSITE-V 1 Vacuum (shown with Suction Foot, Left) COMPRESSION SFR Standard 1 Foot, Right SFL Standard 1 Foot, Left BFR Big Foot, 1 Right BFL Big Foot, 1 Left CXF CX Foot VFR Suction Foot, 1 Right VFL Suction Foot, 1 Left 07231RET OPTRAC* 1 Retractor POSUT OPTRAC 1 Suture Stay CO202 Filtered 6 CO2 Blower w/mist, 15 cm Malleable Shaft SUCTION RETRACTOR ACCESSORIES RXF RX Foot 1

6 PO Box 151, Somerville, NJ SUMMARY OF LABELING FLEXSITE* HEART STABILIZER INDICATIONS FOR USE The PRECISION-OP* System is indicated for patients undergoing cardiac surgery requiring a median sternotomy. The PRECISION-OP* System is intended to provide access to the thoracic cavity, and to retract, position and stabilize the heart. CONTRAINDICATIONS None known. WARNINGS AND PRECAUTIONS The FLEXSITE* Stabilizer is intended for single use only. DO NOT resterilize or REUSE. The FLEXSITE* Stabilizer feet are intended for single use only. DO NOT resterilize or REUSE. The Suture Stays are intended for single use only. DO NOT resterilize or REUSE. The OPTRAC* Retractor must be cleaned and sterilized according to the Care and Handling Instructions prior to each use. Failure to properly clean and dry the OPTRAC* Retractor may lead to inadequate sterilization and reduction in usable life of the instrument. Always completely dismantle the OPTRAC* Retractor prior to cleaning and sterilization. Ensure that all Suture Stays have been removed and disposed of prior to cleaning and sterilization of the OPTRAC* Retractor. 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. Do not adjust or open the OPTRAC* Retractor with the stabilizer foot positioned on the epicardium. When removing the stabilizer from the epicardium, care should be taken not to disrupt the anastomosis site. Take care not to adjust or move the OPTRAC* Retractor while retraction sutures are engaged in the Suture Stays. The Suture Stays are designed for use with size 0 sutures. Do not use with other suture sizes. For more information about products and training, contact your local CardioVations Specialist or visit To place an order, call *Trademark 2001 CV027