Vaginal Balloon Packing System

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Presentation transcript:

Vaginal 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. A-PE-1113-REV06

What we like What we don’t like Vaginal Packing 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 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.

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.

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.

74% Improvement in rectal displacement 57cGy Clinical Studies 32% Reduction in bladder dose 11% Reduction in rectal dose 400 Patient Treatments Data Collected 74% Improvement in rectal displacement 57cGy Average reduction in rectal dose 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.

Dose Reduction Mary Bird Perkins Cancer Center Direct dosimetry comparison between patients treated with and without the Alatus System 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 S405-406 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. 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.

Study Parameters 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. 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.

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.

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.

Reduction in bladder dose Dose Reduction 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 I like this format where it comes in automatically, keep this for all conclusion slides 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.

Anatomical Optimization H. Lee Moffitt Cancer Center Direct dosimetry comparison of Alatus and gauze packing in 5 patients 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) 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.

Anatomical Optimization 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 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.

CT Based Planning Alatus 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. Alatus System

55cGY Anatomical Optimization Dose with Packing minus Dose with Alatus Bladder Dose (cGy) Rectum Dose(cGy) 0.1 cc +93.2 +65.2 0.2 cc +93.1 +62.4 0.5 cc +56.7 +61.6 1 cc +35.9 +58.8 2 cc +32.9 +58.4 5 cc +38.3 +38.9 55cGY Average reduction in rectal dose I’d like to convert this data into a graph, this cut and paste from the study is confusing. Lets work on something new after I can explain what this information is actually saying. 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.

Anatomical Optimization 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. 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.

Anatomical Optimization University of Pennsylvania The first study tp analyze the use of the Alatus System with various sedation methods 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. 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.

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.

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.

Anatomical Optimization 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. This is the conclusion slide to the anesthesia reduction data found in the ASTRO prezi, but all the other slides but one are missing from this copy 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.

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.

Anatomical Optimization 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. 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.

Contrast Attenuation H. Lee Moffitt Cancer Center The Alatus Device can be filled with contrast for further dose reduction through attenuation 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. 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.

74% MRI simulations VBP vs. Packing Improvement in rectal displacement Were is the side by side comparison image???? 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.

Testimonials MATT BIAGIOLI, M.D. Brachytherapy Service Chief Department of Radiation Oncology H. Lee. Moffitt Cancer Center and Research Institute "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." 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.

Testimonials CHARLES WOOD, M.D. “Our early experience with the RadiaDyne balloon thus far has been quite positive, with less patient discomfort and markedly increased reproducibility as compared to traditional packing. We are hopeful that this will translate into increased bladder/rectal sparing on a consistent basis."  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.

Testimonials SHELDON JOHNSON, M.D. "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" 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.

Testimonials YI-JEN CHEN, M.D. “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." 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.

Questions? RadiaDyne.com [TF] 8 8 8 . 7 8 8 . 4 3 7 1 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.