The Future is Evident. Introducing the Evident TM Microwave Ablation System

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Job Clark
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1 The Future is Evident Introducing the Evident TM Microwave Ablation System

2 As the world leader in energy-based therapies and surgical solutions for more than 40 years, we provide innovative technologies for top surgeons worldwide. Our dynamic portfolio of energy-based systems, devices and therapies stand as a testament to the confidence and trust that our customers have in our company. Introducing the Evident TM Microwave Ablation System In 2007, Tyco/Healthcare/Valleylab separated from parent company Tyco International and emerged as Covidien an independent $10 billion global leader in healthcare products. Newly rebranded as Covidien, Valleylab is now referred to as the Energy-based Devices Global Business Unit (GBU) of Covidien. For more than 40 years, Covidien Energy-based Devices has led the medical device industry in developing and manufacturing advanced, energy-based surgical systems and devices that help physicians better serve the healthcare needs of patients worldwide. With the Interventional Oncology product line, Covidien will continue in the delivery of effective, leading medical devices that improve procedural efficiency and patient safety. Microwave ablation uses rotation of water molecules to create frictional heat, which results in an ablation zone. This 915 MHz system can create a contiguous ablation zone at 45 W in 10 minutes. Up to three antennas can be activated at once, producing three lesions or one large lesion (spacing of cm) in just 10 minutes. With microwave ablation, there s no current flow through the patient, eliminating the need of grounding pads. The microwave ablation antenna radiates an energetic field into tissue, which creates an active zone of heating, rather than relying on thermal conduction and current flow. The system is targeted for soft tissue. To activate, insert the entire green radiating section into the target tissue. The system automatically shuts off when the ablation cycle is complete. Use image guidance for additional confirmation and confidence that the ablation zone has been achieved. 2

Ev ident TM Microwave Ablation System is the fastest ablation system for soft-tissue coagulation Fastest system available; ablation procedure time reduced by more than 60 percent* Easy to set up

3 Ev ident TM Microwave Ablation System is the fastest ablation system for soft-tissue coagulation Fastest system available; ablation procedure time reduced by more than 60 percent* Easy to set up Creates a larger zone of active heating** and is not directly affected by impedance*** * Reference to fastest ablation system: Marketing Language (RITA RFA for Liver Tumor Protocol, Boston Scientific Customer Notification Letter dated 7/29/05) ** References for larger zone of active heating: Wright AS, Lee FT, Mahvi DM. Hepatic microwave ablation with multiple antennae results in synergistically larger zones of coagulation necrosis. Ann Surg Oncol. 2003;10: ; Wright AS, Sampson LA, Warner TF, Mahvi DM, Lee FT Jr. Radiofrequency versus microwave ablation in a hepatic porcine model. Radiol. 2005;236(1): ; Simon CJ, Dupuy DE, Iannitti DA, et al. Intraoperative triple antenna hepatic ablation. Simon CJ, Dupuy DE, Iannitti DA, et al. Intraoperative triple antenna hepatic microwave ablation. AJR Am J Roentgenol. 2006;187(4):W *** Reference for not directly affected by impedance: Wright AS, Sampson LA, Warner TF, Mahvi DM, Lee FT Jr. Radiofrequency versus microwave ablation in a hepatic porcine model. Radiol. 2005;236(1): ; Haemmerich D, Lee FT Jr. Multiple applicator approaches for radiofrequency and microwave ablation. Int J Hyperthermia. 2005;21(2):93-106; Martin RC 2nd, Scoggins CR, McMasters KM. A phase II study of radiofrequency ablation of unresectable metastatic colorectal cancer with hepatic arterial infusion pump chemotherapy. J Surg Oncol. 2006;93(5):

4 Open Surgical Antenna Antenna needle Radiating portion of tip (green) Feed point Ablation Zone Examples The following are examples of anticipated ablation results using single and multiple MWA surgical antennas. These examples are from ex-vivo animal-tissue (liver) models. The size of ablation zones may vary in clinical settings. Microwave connector Flexible cable in cable-management system Clips Single MWA Surgical Antenna The following illustration and tables depict an ablation zone created by a single surgical antenna at various power and time settings. The shaded regions in the images represent the zone of tissue coagulation created around the antenna. Multiple MWA Surgical Antennas The following illustration and table depict the approximate size of an ablation zone created by three antennas energized simultaneously at 45 W for 10 minutes using various spacings. B B A S A Perpendicular to axis of antenna C In the plane of the antenna C 45 Watts 3 Minutes 5 Minutes 10 Minutes A 1.7 cm 2.2 cm 3.2 cm B 4.0 cm 4.5 cm 5.2 cm C 0.2 cm 0.4 cm 0.4 cm 45 Watts 1.5 cm 2.0 cm 10 Minutes Spacing (S) Spacing (S) A 4.5 cm 5.2 cm B 7.0 cm 6.5 cm C 0.8 cm 0.8 cm 4

Percutaneous/Laparoscopic Antennas Ablation Zone Examples The following are examples of anticipated ablation results using single and multiple MWA percutaneous antennas.

5 Percutaneous/Laparoscopic Antennas Ablation Zone Examples The following are examples of anticipated ablation results using single and multiple MWA percutaneous antennas. These examples are from ex-vivo animal-tissue (liver) models. The size of ablation zones may vary in clinical settings. Microwave connector Antenna needle Inflow-tubing connector (Shorter tube with blue stripe) Radiating portion of tip (green) Feed point Outflow-tubing connector (Longer clear tube) Flexible cable in cable-management system Clips Single MWA Percutaneous Antenna The following illustration and table depict an ablation zone created by a single MWA percutaneous antenna at various power and time settings. The shaded regions in the images below represent the zone of tissue coagulation created around the antenna. B Multiple MWA Percutaneous Antennas The following illustration and table depict the approximate size of an ablation zone created by three MWA percutaneous antennas energized simultaneously at 45 W for 10 minutes using various spacings. B A S A Perpendicular to axis of antenna C In the plane of the antenna C 45 Watts 3 Minutes 5 Minutes 10 Minutes A 1.8 cm 2.3 cm 2.9 cm B 3.9 cm 4.2 cm 4.8 cm C 0.4 cm 0.5 cm 0.6 cm 45 Watts 1.5 cm 2.0 cm 10 Minutes Spacing (S) Spacing (S) A 4.3 cm 5.0 cm B 6.3 cm 5.5 cm C 1.0 cm 1.0 cm 5

6 MWA Product Specifications Radiating Product Description Total Length Section MW Ablation Generator VTGEN Evident TM MW Ablation Generator Pump and Cart VTPUMP VTCART Evident TM MW Ablation Pump Evident TM MW Ablation Cart Percutaneous Antennas VT1237 VT1737 VT2237 Evident TM MWA Percutaneous Antenna 12 cm 3.7 cm Evident TM MWA Percutaneous Antenna 17 cm 3.7 cm Evident TM MWA Percutaneous Antenna 22 cm 3.7 cm Surgical Antenna VTS1737 Evident TM MWA Surgical Antenna 17 cm 3.7 cm Pump Tubing for Percutaneous Antenna VTUBE Evident TM MWA Pump Tubing and Chamber 6

Includes VTGEN VTPUMP VTCART MW Ablation Generator MW

7 Product Description Rental VTSYSRENTAL Evident TM MW Ablation Three Generator System Daily Rental* Rental Includes VTGEN VTPUMP VTCART MW Ablation Generator MW Ablation Pump MW Ablation Cart *Antennas not included 7

8 COVIDIEN, COVIDIEN with logo and positive results for life are trademarks of Covidien AG Covidien AG. All rights reserved. reorder no: LMWEVIDENTBR / Lo n g b o w Dr i v e Bo u l d e r, CO [t] w w w.c o v i d i e n.c o m

Microwave ablation of liver metastases to overcome radiofrequency ablation limits

Microwave ablation of liver metastases to overcome radiofrequency ablation limits Poster No.: C-2456 Congress: ECR 2012 Type: Scientific Exhibit Authors: G. Carrafiello 1, A. M. Ierardi 1, V. Molinelli