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Vaginal Balloon Packing System A-PE-1113-REV06 Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking.

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Presentation on theme: "Vaginal Balloon Packing System A-PE-1113-REV06 Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking."— Presentation transcript:

1 Vaginal Balloon Packing System A-PE-1113-REV06 Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

2 What we like Displaces OAR away from dose Immobilizes the applicator and adjacent anatomical structures What we don’t like Time consuming procedure Traumatic for the Patient Reproducibility concern Vaginal Packing Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

3 How The System Works The Alatus System works with your existing applicator to optimize the patient’s anatomy Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

4 How The System Works Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

5 400 Patient Treatments Data Collected 32% Reduction in bladder dose 11% Reduction in rectal dose 74% Improvement in rectal displacement 57 cGy Average reduction in rectal dose Clinical Studies Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

6 Mary Bird Perkins Cancer Center Evaluation of a Balloon-Based Vaginal Packing System for Brachytherapy of Cervical Carcinoma M. Price, J. Fontenot, M. Sanders, S. Johnson, C. Wood Intl J. Radiat Oncol Bio Phys, Vol. 78, Issue 3, Supplement page S Purpose: Evaluates the use of intracavitrary balloons to replace conventional methods for intracavitrary brachytherapy (ICBT) where a tandem and ovoid applicator (TOA) is utilized. Dosimetric advantages, with respect to reductions in dose to OAR as well as clinical efficacy and improvements in patient comfort are considered. Direct dosimetry comparison between patients treated with and without the Alatus System Dose Reduction Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

7 Materials and Methods: 11 packing fractions vs. 14 Alatus fractions where analyzed Comparison of dosimetric advantages in respect to OAR dose reduction along with assessment of patient comfort was made. Study Parameters Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

8 Standard Vaginal Packing Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

9 Alatus Balloon Packing System Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

10 Conclusions: Considering D2cc, the balloon-based packing method resulted in significant reduction in dose to the bladder and rectum for ICBT patients treated with TOA. A similar reduction was also observed for average ICRU bladder point dose. In addition, improved patient comfort has lead to permanent clinical implementation of this packing system. 32% Reduction in bladder dose Dose Reduction Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

11 H. Lee Moffitt Cancer Center Initial Experience with Alatus Vaginal Balloon Packing (VBP) Compared to standard Vaginal Gauze Packing (SGP) for Tandem and Ovoid Brachytherapy Treatment of Carcinoma of the Cervix M. Ahmed, A. S. Saini, D. Hunt, W. Skinner, S. E. Finkelstein, M. C. Biagioli Int. J Radiat Oncol Biol Phys Vol. 78, Issue 3, Supplement page S417 Purpose: Report initial experience with vaginal balloon packing (VBP) compared with standard gauze packing (SGP) Direct dosimetry comparison of Alatus and gauze packing in 5 patients Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

12 Study Parameters – Materials and Methods: 8 consecutive patients undergoing fractionated HDR brachytherapy with Tandem and Ovoid Each fraction was alternatively packed with either Gauze Packing or Alatus VBP Dosimetry for point A, Rectum, Bladder and HRCTV were determined both according to ICRU and GEC-ESTRO based planning Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

13 Alatus System CT Based Planning Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

14 Dose with Packing minus Dose with Alatus 55 cGY Average reduction in rectal dose Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

15 Conclusions Both rectal and vaginal dosimetry favored Alatus balloon packing over Standard Gauze packing whether planned according to GEC-ESTRO or ICRU point A calculations. Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

16 University of Pennsylvania Evaluation of a balloon-based vaginal packing system and patient-controlled analgesia for patients with cervical cancer undergoing high-dose-rate intracavitary brachytherapy. Department of Radiation Oncology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania PurposeTo evaluate the following: (1) The dosimetric impact on the bladder and rectum due to methodologic shift from general anesthesia (GA) to patient controlled analgesia (PCA), and from vaginal gauze packing (VGP) to vaginal balloon based packing (VBP) for high-dose-rate (HDR) intracavitary; and (2) The tolerability of PCA versus GA. The first study tp analyze the use of the Alatus System with various sedation methods Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

17 Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

18 Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

19 Conclusions We found the PCA device for patients undergoing T&O brachytherapy with the VBP system to be both feasible and well tolerated. Patients reported a median maximum intra-procedure pain score of 0 (0-2) Though no formal cost comparison was done for this analysis, eliminating the need for operating room space diminished the cost and resources necessary for our HDR brachytehrapy program. This program also reduced the overall time per procedure for the patient, as recovery time from anesthesia was eliminated. Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

20 Dose Reduction Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

21 Conclusions For all patients, the bladder D2cc + ICRU dose and rectum Bladder D2cc + ICRU dose point expressed as a percentage of point A were lower in the group that received VBP compared with gauze packing. Anatomical Optimization Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

22 H. Lee Moffitt Cancer Center Dose Reduction Study in Vaginal Balloon Packing Filled with Contrast for HDR Brachytherapy Treatment Saini S., Zhang G., Finketlstein S., Biagioli M., Intl J Radiat Oncol Biol Phys, Vol. 80, Issue 4, p 1263 – 1267, July 2011 Purpose: To test the hypothesis that contrast-filled vaginal balloon packing reduces radiation dose to organs at risk, such as the bladder and rectum. The Alatus Device can be filled with contrast for further dose reduction through attenuation Contrast Attenuation Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

23 MRI simulations VBP vs. Packing 74% Improvement in rectal displacement Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

24 "In our initial experience using the Alatus vaginal balloon packing system, we found that the Alatus packing was either superior or at least equivalent to traditional vaginal packing in the displacement of bowel and rectum in the same women. This better displacement has resulted in lower radiation doses to both rectum and bladder favoring the Alatus system. Additionally, the Alatus packing has proven more reproducible on a implant to implant basis. Furthermore, when using Alatus packing, our patients have reported less discomfort and required less pain medication both while implanted and with removal of the applicators when compared to traditional packing. After completing our initial evaluation, I cannot imagine ever returning to the use of traditional vaginal packing." Testimonials MATT BIAGIOLI, M.D. Brachytherapy Service Chief Department of Radiation Oncology H. Lee. Moffitt Cancer Center and Research Institute Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

25 Testimonials CHARLES WOOD, M.D. Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

26 "The (RadiaDyne) balloons, compared to conventional vaginal packing materials, are easier to apply and remove, less uncomfortable for the patient, and I expect may result in less dose to bladder and rectum in most patients" Testimonials SHELDON JOHNSON, M.D. Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

27 “We found that the Alatus Vaginal Balloon Packing System is easy to use. In majority of patients, it seems it is comparable or superior in terms of displacement of normal rectum and bladder from the brachytherapy obviously could result in less unnecessary radiation dose to the rectum and bladder and less treatment-related side effects. We also observed less discomfort in patients while removing the balloon compared to removing the vaginal packing system. Studies are needed to confirm the benefit of balloon system." Testimonials YI-JEN CHEN, M.D. Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited.

28 Questions? Data contained in this presentation is the property of RadiaDyne, LLC. Distribution, use, coping, or reworking of confidential proprietary information without permission or authorization is prohibited. RadiaDyne.com [TF]


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