Nurse Educational Program on Genesys HTA System Boston

Nurse Educational Program on Genesys HTA™ System Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 1 of 40

Agenda § Global Endometrial Ablation (GEA) Overview § Benefits of Genesys HTA™ System § Genesys HTA System Procedure Overview o Set Up o Procedure o Break Down § Learn Troubleshooting Techniques Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 2 of 39.

Objective To learn efficient and effective set up and operation of the Genesys HTA™ System Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 3 of 39.

Global Endometrial Ablation Devices – FDA Approval Dates HTA® System & Novasure® System Rollerball 1994 1997 Thermachoice® I Device 2001 Thermachoice® III Device 2003 Thermachoice® II Device 2007 Genesys HTA™ System Global Endometrial ablation devices are continually evolving to meet physician and patient needs Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 4 of 40 2010

Genesys HTA™ System – Evolution 2001 2005 2006 2009 2010 HTA® System Time Line Launch of HTA System Launch of Tenaculum Stabilizer Disposable Heater Canister Flow Rates* § HTA System - 259 cc/min (Mean) § Genesys HTA System – 332 cc/min (Mean) Number of Sensors to detect a Fluid Loss* § HTA System – 3 § Genesys HTA System – 24 Time Savings* – § Genesys HTA System vs. HTA System o - Total time savings- 4: 44 minutes *Data on File- Boston Scientific. Based on 9 Users. Results may vary. Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 5 of 40 HTA Pro. Cerva® Sheath Genesys HTA System

Genesys HTA™ System Benefits Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 6 of 40

The Genesys HTA™ System Benefits The Genesys HTA System is designed for easy set up and intuitive operation to deliver a safe, effective and versatile treatment for menorrhagia. Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 7 of 40

Easy Set Up § Compact cassette with drop in loading § One step fill stage § Easy shut down and restart for quick case turn around § One set up for ablation and concomitant hysteroscopy Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 8 of 40

Intuitive Operation § Dynamic LCD screen § Step by step instructions § On screen display of alerts and alarms § Audio cues o Including Seal Integrity check Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 9 of 40

Designed for Safe Use § § HTA Pro. Cerva Fins Seal Integrity Check o Designed to help verify cervical seal before heat up Fluid monitored during entire procedure ® § Genesys HTA Pro. Cerva® Sheath o Redesigned to gain and maintain a seal at the cervix with 16 redundant soft silicone fins o Incidence of burns since Genesys HTA Pro. Cerva Sheath Introduction - 0. 104% (As of February 29, 2012) § Tapered sieve tip o Return surface area increased ~ 500% o Designed to help prevent clogs § Direct visualization throughout entire procedure (Before, during and after) § Low pressure (50 -55 mm. Hg) Data on File- Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 10 of 40 New Sieve Tip

Effective Amenorrhea Eumenorrhea The highest Phase III clinical amenorrhea rates at three years 1 36 Months 2 1. When compared against Novasure® System, Therma. Choice® I Device and Her Option® System. Evaluated population on the HTA® System. Carter JF, Endometrial Ablation: More Choices, More Options The Female Patient. 2005; 30(12): 35 -40. 2. Evaluated Population, treated with HTA System (72/136). Goldrath MH, Evaluation of Hydro. Therm. Ablator and Rollerball Endometrial Ablation for Menorrhagia 3 Years after Treatment. The Journal of the American Association of Gynecologic Laparoscopists. November 2003, Vol. 10, No. 4. Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 11 of 40 Patient Satisfaction

Versatile § Potential to treat a wide variety of uterine cavities 1 o Intramural fibroids (≤ 4 cm) § Designed to be compact & quiet – Can potentially be use in either in the Office or Operating Room 2 § Continuous hysteroscopic monitoring 1. Evaluated population on the HTA® System. Carter JF, Endometrial Ablation: More Choices, More Options The Female Patient. 2005; 30(12): 35 -40. Reilly GP, Can Endometrial Ablation Technique Effectiveness Be Properly compared without considering the uteruses treated? 2. Phillips R, Schultz M, Patient Pain Tolerance of In-Office Hydro. Thermal Ablation. 2007 AAGL Podium presentation. Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 12 of 40

Use with Essure® Device § The FDA has approved the use of the HTA® System after placement of Essure Mircroinserts 1 o Following 3 month HSG confirmation test 1 1. Essure – ESS 305 Instructions for Use- pg. 1 Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 13 of 40

Genesys HTA™ System Procedure Overview Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 14 of 40

What is Hydro. Therm Ablation? An Overview Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 15 of 40

Equipment Needed for Genesys HTA™ System* § § § Genesys HTA System (control unit) Genesys HTA Pro. Cerva® Procedure Set 3 Liter bag of saline Scope adapter 3 mm or smaller rigid hysteroscope *Refer to Genesys HTA System User Manual for a complete list of equipment needed Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 16 of 40

Set Up, Procedure, Break Down Read, discuss, decide Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 17 of 40

System Setup: Cassette; Drainage Bag Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 18 of 40

System Set Up: Checking Cassette Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 19 of 40

System Setup: Saline, Sheath, Adapter, Scope, Cap Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 20 of 40

System Preparation: System Initializing & Filling Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 21 of 40

System Preparation: Preparing for Diagnostic Hysteroscopy Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 22 of 40

Procedure: Set System Height to Uterine Level All procedure steps up to this point can be performed prior to patient entering in room Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 23 of 40

Procedure: Remove Sheath Cap & Insert Procedure Sheath into Patient Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 24 of 40

Procedure: Diagnostic Hysteroscopy Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 25 of 40

Procedure: Ablation Preparation Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 26 of 40

Procedure: Ablation Preparation – Seal Integrity Check Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 27 of 40

Procedure: System Heating to Ablation Temperature Saline will heat up to 80◦C, then 10 minute ablation cycle will start Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 28 of 40

Procedure: Hit Pause? Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 29 of 40

Procedure: Ablation Procedure Saline will continue to heat up to 90◦C Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 30 of 40

Procedure: Cooling and Flushing Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 31 of 40

Procedure: Patient Cooling Complete Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 32 of 40

Procedure: Procedure Complete Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 33 of 40

Break Down: System Shutdown Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 34 of 40

Break Down: System Shutdown Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 35 of 40

Procedural Reminders*: § Continuously monitor the cervical seal § Avoid allowing the procedure sheath tubing to contact patient § Avoid moving or removing the procedure sheath until the post-treatment cooling cycle has been completed § Avoid over-dilatation § Maintain a stable sheath position throughout the procedure * Refer to User’s Manual for all contraindications, warnings and cautions associated with using the Genesys HTA™ System Image Source: Master isolated images http: //www. freedigitalphotos. net/images/Office_and_Stationer_g 145 -Push_Pin_p 34736. html Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 36 of 40

Troubleshooting Alarms § Read, discuss, decide Refer to the User’s Manual for all troubleshooting information when using the Genesys HTA™ System Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 37 of 40

Troubleshooting Fluid Loss Detected Alarms* § User actions for fluid loss alarms: o Ensure sheath is positioned beyond the internal cervical os to ensure proper fluid flow o If there is cervical leakage, consider adding second tenaculum § If fluid loss alarms continue o o Consider procedure cancellation Call Rep * Refer to User’s Manual for all troubleshooting information when using the Genesys HTA™ System Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 38 of 40

Conclusion It is as easy as…. Read, discuss, decide Genesys HTA, Genesys HTA Procerva, HTA Procerva and Uterine Health Institute are registered or unregistered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are property of their respective owners. Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 39 of 40

Disclaimers § Refer to Genesys HTA™ System Installation and Operator’s Manual provided with product for complete instructions for use. § INDICATIONS: The Genesys HTA System is a hysteroscopic thermal ablation device intended to ablate the endometrial lining of the uterus in premenopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete. CONTRAINDICATIONS: The Genesys HTA System is contraindicated for use in a patient: who is pregnant or wants to be pregnant in the future, as pregnancy after ablation can be dangerous to both mother and fetus; who has known or suspected endometrial carcinoma or premalignant change of the endometrium, such as adenomatous hyperplasia; who has active pelvic inflammatory disease or pyosalpinx; hydrosalpinx; in whom a tight cervical seal cannot be established and maintained around the procedure sheath; who has any anatomical or pathologic condition in which weakness of the myometrium could exist, such as, prior classic cesarean section or transmural myomectomy; who has an intrauterine device in place; or who has active genital or urinary tract infection, e. g. , cervicitis, endometritis, vaginitis, cystitis, etc. , at the time of treatment. POTENTIAL ADVERSE EFFECTS that may occur include: pain, cramping, nausea, vomiting, bleeding, infection, laceration, Endometritis, thermal injury to adjacent tissue including cervix, vagina, vulva, and/or perineum; heated saline escaping from the device system into the vascular spaces; hemorrhage; perforation of uterus; complications with pregnancy (Note: pregnancy following ablation is dangerous to both the mother and the fetus); risks associated with hysteroscopy, complications leading to serious injury and death, post-ablation tubal sterilization syndrome, and delayed diagnosis of cancer of the endometrium. § WARNINGS: NOTE: Failure to follow any instructions or to heed any Warnings or Precautions could result in serious patient injury. § CAUTION: Federal Law restricts this device to sale by or on the order of a physician. The physician using the device must be trained in diagnostic hysteroscopy. Boston Scientific Confidential - Do Not Copy, Display or Distribute Without the Written Permission of Boston Scientific Corporation or its Affiliates. © 2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. WH-67501 -AA; 3/2012; slide 40 of 40