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“ A better way to treat accessible tumours ” One System: Multiple Treatment Options X-ray Brachytherapy Breast Treatment Skin Treatment Rectal Treatment

A better way to treat accessible tumours ”

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Page 1: A better way to treat accessible tumours ”

“ A better way to treat accessible tumours ”

One System:Multiple Treatment

Options

X-ray Brachytherapy

BreastTreatment

SkinTreatment

RectalTreatment

Page 2: A better way to treat accessible tumours ”

Rectal ‘Papillon’ Treatment

Contact Brachytherapy is a treatment modality where radioactive sources are placed near a tumour. Compared to external beam radiation therapy, brachytherapy delivers high doses directly to the tissue with rapid dose fall off, reducing radiation exposure to healthy tissues. Traditional radionucleotide brachytherapy deals in high energies, resulting in toxicity, the need for suitable shielding and problems associated with the handling of radioactive isotopes.

The Papillon+™ Brachytherapy system replaces radioactive sources with low energy 30 or 50 kVp X-rays. As a result, the Papillon+™ system combines the advantages of targeted treatment volumes and a high dose rate but without the accompanying need for significant shielding and a reduction in toxicity. Resulting in dramatically reduced treatment times and increased patient comfort.

X-Ray Brachytherapy: One System, Many Solutions

BreastTreatment

SkinTreatment

RectalTreatment

X-ray Brachytherapy

>12Gy/min, 50% PDD at 5mm (50 kVp, 2.1 mA)HVL 0.5 – 0.8 mm Al equivalent

Accelerated PartialBreast Irradiation (APBI)

Up to 300° spherical dose distribution, >5 Gy/min (50 kVp, 1.0 mA)HVL 0.7 – 1.0mm AL equivalent

Super�cial Skin Treatment

>7 Gy/min (50 kVp, 2.1 mA)HVL 0.5-0.7mm AL equivalent with 30mm applicator

An increased consideration for Quality of Life combined with an aging population has driven demand for organ-sparing options for “operable” patients with manageable tumours in the lower third of the rectum; as well as those unsuitable for anaesthesia or with significant co-morbidities.The Papillon+™ delivers a curative dose of 30Gy per fraction (av. 90Gy per treatment) directly to the tumour. Papillon has been successfully used on over 3000 patients across Europe either as part of a “Watch & Wait” strategy either as a sole treatment or in conjunction with EBRT & Chemotherapy.

X-Ray Brachytherapy allows clinician to offer a single IORT boost in place of the traditional post-surgical 3-5-week External Beam radiation regime. Whilst this is an attractive option to both patients and clinicians the long delivery times associated with its delivery and concerns about depth of beam penetration have led to questions about its viability.The Papillon+™ addresses those concerns, delivering the prescribed dose of 20Gy directly to the tumour bed (immediately post tumour excision) in as little as 1-5 minutes. The rapid intensity fall-off beyond the treatment target also avoids delivering potentially damaging radiation to underlying tissue and organs whilst still delivering 50% of dose at 5mm ensuring a secured surgical margin.

Low energy, low dose radiotherapy has long been recognized as a treatment option for basal cell and squamous cell skin cancers. Our previous Papillon 50 system has been used to treat 1000’s of patients across Europe for the past 10 years.The new Papillon+™ takes that direct control associated with superficial cancer treatment but incorporates Ariane’s proprietary collimation system. This bespoke shielding system facilitates control of field shape to conform with irregular target areas and protect delicate adjacent tissues; reducing time consuming shield development to a matter of minutes.

Page 3: A better way to treat accessible tumours ”

1 Local excision of the tumour (lumpectomy)

Insert and correctly position with Ariane’s Breast Applicator 2

The applicator position is locked 3

4 Connect the Micronode™ X-ray generator and deliver 20Gy

Position the applicator, guided by direct vision, having selected the size that fits the cavity.

Spherical applicators are available in sizes 25 to 50mm diameter.

An articulated arm supports the applicator, ensuring its position is maintained throughout the treatment.

Sterile and radiation protection barriers are fitted over the support arm and patient.

5MINUTES

1-4MINUTES

2MINUTES

Treatment of Breast Cancer with

BreastTreatmentApplicators

X-ray Brachytherapy

The transmission anode of the X-ray tube is automatically located at the centre of the spherical applicator to ensure homogenous irradiation of the excised cavity wall.

Page 4: A better way to treat accessible tumours ”

1

2

3

Following a simple out patient preparation procedure an applicator of appropriate size is inserted into the rectum with minimum discomfort.

A video microscope is used to align the applicator onto the treatment site.

The support arm is locked to maintain the correct position and if necessary the treatment site is cleaned.

The Micronode®. X-ray source is coupled to the applicator and the radiation dose is delivered.

The applicator position is monitored with a video microscope incorporating movement detection throughout the treatment.

Insert Rectal Applicator

Position

Radiation Delivery

3MINUTES

4MINUTES

3MINUTES

RectalTreatmentApplicators

Treatment of Rectal Cancer withX-ray Brachytherapy

Page 5: A better way to treat accessible tumours ”

Place scaling dot next to the tumour and take an image using a digital camera.

Fit computer cut shielding insert into holding cover and align with tumour.

Position collimating applicator on to the holding cover and treat.

1

2 Radiation Delivery

Fit the applicator to the Micronode generator having attached a collimation insert where needed.

3MINUTES

4MINUTES

Align the applicator with the treatment site and apply the brakes.

The applicator position is monitored with a video microscope incorporating movement detection throughout the treatment.

Mount the Applicator

SkinTreatmentApplicators

Treatment of Skin Cancer withX-ray Brachytherapy

Page 6: A better way to treat accessible tumours ”

The on-board consistency checking system provides a convenient means to confirm dose, energy and beam characteristics have not deviated from the reference measurements prior to treatment.

Prefectus QA

The Papillon+™ X-Ray Brachytherapy is a low cost, mobile, delivery system which offers single or multiple treatment options within one platform. The rectal ‘Papillon’ treatment option offers reduced surgical and hospital time care cost reductions along with ongoing Stoma and nurse expenses, all based around an outpatient clinic set-up. The IORT breast treatment can deliver the trial affirmed treatment dose in just a couple of minutes, freeing up valuable Operating Room and staffing time compared to other systems on market. The Skin application is perfect for the ever growing number of superficial cancer cases and by utilising our new Irregular field shielding technique it ensures a quick treatment delivery without surgical cost whilst, freeing up expensive Linac or HDR time being used. The low level shielding requirements along with a remote door security and QA systems allow for safe room use without any capital expenditure on OR modifications. One system – Multiple treatments.

Business Case

An optional system with radiation on alert lights and incorporates a wireless communication module that interfaces with door warning units and an encrypting multiplexer that combines warning status information with X Ray generator, activation switch and Prefectus QA control.

Monitus Door Warning System

A Turnkey Solution

Page 7: A better way to treat accessible tumours ”

Product Speci�cation

Energy (kVp)

HVL (mm AI.)

Focal spot diameter

Dose-rate at 20 mm FSD

Useful anode rod length

Anode rod diameter, total

Beam angle, maximum

Duty cycle @ 25 degrees C. ambient

Power requirement

Applications

Treatment termination, primary

Treatment termination, secondary

30 or 50

0.25 - 0.8

4 mm

Up to 20 Gy/min (Application dependant)

17 cm

17 mm

310 degrees

Continuous

X Ray Generator, battery powered. Workstation battery powered.

(Battery charger included)

Breast, Rectal, Skin, general IORT(all require the appropriate accessory package)

For further details please see product speci�cation documents and site planning guide

Pseudo dose (anode MAS)

Independent timer with battery back up supply

Further treatment modalitiesunder development ..

General IORT Head & NeckThe ability of the Papillon+™ X-ray brachytherapy system to operate at both 30 & 50 kVp, with and without filtration offers bespoke treatment planning solutions for head, neck and intra-oral cancers.

The Papillon+™ X-ray Brachytherapy system offers a simple and accurate means of delivering a localised “boost” during surgery to complement regional EXBRT. The 17mm thick, 20cm long X-ray tube offers a unique IORT treatment capability.

Page 8: A better way to treat accessible tumours ”

Represented by:

Images courtesy of;Professor J-P Gerard, Hospital Lacassagne, Nice, France.Dr N Barbet, Polyclinique Du Val de Saône, Macon, France.Professor A Sun Myint, Clatterbridge Cancer Centre, Liverpool, UK.

www.arianemedicalsystems.com

Ariane Medical Systems Limited151 Mansfield Road, Alfreton DE55 7JQ UK

Tel: +44 (0) 1332 242258

We reserve the right to make changes to the products described in this material without giving prior notice Issue 4.0

X-ray Brachytherapy

High dose rate - up to 20 Gy/min* *application dependant

Low shielding requirements

Turnkey/Multi-mode solution

Mobile & Wireless

Cost effective

WinnerINNOVATION AWARD 2018 / 2019Medilink East Midlands Business Awards