Introduction to Qfix and the Encompass SRS … and Encompass SRS system... · Qfix ConfidentialQfix Confidential 11 Introduction to Qfix and the Encompass SRS Immobilization System

Qfix Confidentialwww.Qfix.com 1Qfix Confidentialwww.Qfix.com 1

Introduction to Qfix and the Encompass SRS

Immobilization System

Presented to Expertgroep Moulage, November 3rd, 2017

Qfix Confidentialwww.Qfix.com 2

Company Overview

• WFR Aquaplast - 1975• Over 40 years

• Specialty: Thermoplastic Material / Masks

• Damon Kirk

• Anholt Technologies - 1991• Over 25 years

• Specialty: Composites, Engineering

• Dan Coppens


Company Overview (Cont.)

• Qfix formed as joint venture 2001

• 2 companies consolidated 2008

• 130+ Employees

• One location: Avondale, PA


Located in Avondale, PA


Company Overview (Cont.)

• Key focus: Radiation Oncology market

• Specialty: Patient Positioning & Immobilization

• Inventors of Aquaplast

• US: Direct selling via Qfix Sales Managers

• Vertically Integrated • Engineering, Manufacturing, Distribution

• Core competency includes polymers and material science engineering


International Market

• 60+ distributors focused on Radiotherapy market

• Service 70+ Markets

• Use exclusive distribution model

• Half of our production ships outside the US


OEM Partnerships

• Varian• Calypso kVue

• Access 360 Prone Breast

• Couchtop in EDGE radiosurgery package

• Positioning devices in EDGE radiosurgery package

• Masks validated for use with OSMS

• Encompass selected as a pre-requisite for use with HyperArc

• Siemens• CT and PET CT overlays

• Insight MRI Overlay


Clinical Partnerships

• Clinical Developmental Sites:• Henry Ford Hospital (Encompass)

• Ohio State (Access 360 Prone Breast)

• Massachusetts General Hospital (BoS Headframe)

• HMC (Hexapod version of the Encompass)

• Loma Linda (Various Proton devices)

• Paul Scherrer Institute (PSI) (Proton immobilization)


• Orlando, FL 2009

• Las Vegas, NV 2010

• Birmingham, UK 2010

• Puerto Rico (Regional) 2011

• Orlando, FL 2011

• New Orleans, LA 2012

• Las Vegas, NV 2013

• Orlando 2014

• Baltimore 2015

• Miami (Regional) 2015

• Greensboro, NC 2016

• Las Vegas, NV 2017/2018


Qfix Product Portfolio

• Thermoplastics: Aquaplast RT™ & Fibreplast™

• CT Overlays and Treatment Couch Tops: kVue™ & Quantum

• SRS: Encompass™

• Intracranial, Head & Neck: Portrait™, AccuFix™, etc

• SBRT: DoseMax™, Stradivarius, Compression Belt, etc

• Respiratory Gating: SDX

• Supine & Prone Breast: Access Family of Treatment Devices

• Prostate, Pelvis & Extremity

• Patient Transport

• MRI

• Proton

• Aids & Accessories: Markers, Cushions, Positioners, etc.


Thermoplastics


Thermoplastics

Portrait S-Frames

Portrait Split S-Frames

U Frames

Split U Frames

BoS Frames

Other Systems


S-Type Thermoplastics

Variable Perf™

Head-Only Head and Shoulder

Split-Frames

Variable Perf is the perfect balance between rigid fixation and patient comfort. The optimal perforation pattern maximizes rigidity while minimizing the bolus effect.

Split-Frames reduce the stretching required of the thermoplastic forming a more rigid mask. These masks also accommodate patients that have long hair.


U-Frame Thermoplastics

Variable Perf™

Slimline U-FramesTraditional U-Frames

Split-Frames

Variable Perf is the perfect balance between rigid fixation and patient comfort. The optimal perforation pattern maximizes rigidity while minimizing the bolus effect.

Split-Frames reduce the stretching required of the thermoplastic forming a more rigid mask. These masks also accommodate patients that have long hair.


Variable Perf™ in Aquaplast™ and Fibreplast™

The optimized perforation

pattern containing low and

high percentage open areas

maximizes mask rigidity while

minimizing the bolus effect that

can result in skin reactions.

Variable Perf masks feature

innovative perforated struts.

They are more rigid and

lower attenuating than

traditional masks that are

reinforced with solid strips.


Assure™ Open View in Fibreplast™

Assure Open View Masks are the perfect balance between rigid

fixation and patient comfort!

• Split-Frame design with Fibreplast™ maximizes rigidity of the mask

• Open View design increases comfort by allowing the patient to see

and breathe easier

• Compatible with Optical Tracking Systems for enhanced patient

setup and real time tracking

• Chin reinforcement for extra rigidity


BoS™ (Base of Skull) Headframe

• Specifically Designed for Proton

Therapy

• Conformal shape eliminates Steep

Gradients

• MRI compatible version available

• Available as a kVue Insert or a stand

alone overlay


BoS™ Headframe (Cont.) BoS™ Headframe

Examples of beam angles that can be

impacted by edge effects (red arrows) and

those that are not (green arrows).

Traditional Photon device

Example of a contoured head/neck

support with a frameless mask design to

reduce range uncertainty from edge

effects.

Wroe, A. J., Bush, D. A., Stater, J. D., Immobilization Considerations for Proton Radiation Therapy. Technology in Cancer Research & Treatment 2013 September 20.



Stereotactic radiosurgery (SRS) Overview

Stereotactic radiosurgery (SRS) delivers high doses of radiation to treat tumors with great precision. SRS is a technique that is most commonly used for tumors or other medical conditions in the brain or central nervous system (CNS). SRS treatments use high precision, accuracy, and sophisticated 3-D imaging to deliver a concentrated dose of radiation in a single or in two to five fractionated treatments.


Qfix Encompass™ SystemProject Objectives

• Immobilization equal to or better than existing solutions.

• Improved workflow efficiencies.

• Enhance patient comfort and reduce patient anxiety.

• Increase patient throughput.

• Improve patient outcomes.


Encompass™ System Overview

• Rigid carbon fiber device designed for low attenuation.

• 3 versions for a complete simulation through treatment solution.

kVue™ InsertStandalone Device MRI/Treatment Compatible Device


Indications

• 510(k) Clearance for Stereotactic Radiosurgery

• Clinical objective is to achieve sub-millimeter immobilization to

precisely treat multiple lesions with a single isocenter.


Encompass™ Fibreplast™ System

Anterior and Posterior Fibreplast™ thermoplastic.

• Anterior thermoplastic is a Variable Perf™ Split Frame for improved

drapeability and increased rigidity.

• Posterior thermoplastic is a single piece frame designed for

improved workflow.

• Thermoplastic covers the Vertex of the patients head for increased

immobilization.

Anterior Posterior


Integrated Shim System™

Integrated shim built into the thermoplastic frames.

• Initial mask molding done with 2mm of shim.

• Simply rotate the pins to adjust the height of shim in the

thermoplastic frame. (+/-2mm)


Encompass™ Fibreplast™ System

• Patient comfort and reduced anxiety.

• Provides enhanced immobilization and reproducibility.

IntegraBite™

Assure™ open view design


Encompass™ System

• Qfix 2 step molding process vs. 3+ steps with competing device,

improves workflow and reduces setup time leading to greater

patient comfort and reduced patient anxiety.

VS.


Encompass™ System

• Integrated shim system™ minimizes components.

VS.


Encompass– Motion Management/Accuracy

• Goal: Multiple lesions with a single Isocenter

15 min Resting

Forced Motion

Table1: Resting motion. All data in mm and degrees. The S- columns represent 2 SD

Table2: Forced motion. The ∆ column represents change in position before

and after forced motion. The Max column is maximum displacement during

forced motion.Data provided by Dr. David Wiant of Cone

Health using Vision RT System


Encompass™ Intra-fraction Motion Data

Data provided by Dr. Salim Siddiqui from Henry Ford Health


Henry Ford Conclusions on Encompass™

• The Edge™ Radiosurgery LINAC system has been shown to possess high accuracy localization and delivery requirements for safely treating patients with tumors in the CNS using SRS/SBRT-based techniques.

• N. Wen, et. al., “Characteristics of a Novel Treatment System for Linear Accelerator–based Stereotactic Radiosurgery”, J. App. Clin. Med. Phys. Accepted (2015)

• Y. Huang, et. al., “Targeting Accuracy of Image-Guided Radiosurgery for Intracranial Lesions: A Comparison across Multiple Linear Accelerator Platforms”, Technol. Cancer. Res. Treat. Accepted (2015)

• VMAT techniques afford plans to treat multiple targets using a single isocenter. The plans demonstrate low isodose spill and afford significantly reduced treatment times.

• The Encompass™ SRS mask system effectively and reproducibly immobilizes patients for SRS treatments with sub-millimeter accuracy and allows for OSMS real-time monitoring during treatment.

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Introduction to Qfix and the Encompass SRS … and Encompass SRS system... · Qfix ConfidentialQfix Confidential 11 Introduction to Qfix and the Encompass SRS Immobilization System