SAVI® Brachy

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SAVI Brachy - Merit Medical - Reducing the Burden of Cancer

TARGETED ACCELERATED PARTIAL BREAST IRRADIATION (APBI) IN JUST 2-5 DAYS* REDUCES PATIENT INTERACTIONS

SAVI Brachy offers a strut-based approach to tissue-sparing dosimetry and is designed to maximize ease of use during placement while providing unparalleled dose customization. Three-fraction treatment protocol with SAVI allows effective APBI treatment to be completed in as little as 2 days2, significantly decreasing contact interactions between patients and medical staff.

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INTRODUCING SAVI BRACHYTHERAPY

SAVI Brachy uses thin tubes (catheters) to deliver radiation directly to the lumpectomy site. The catheters gently expand to fit the size and shape of the tumor cavity. A tiny radiation seed travels through each catheter to deliver a precise dose of radiation, customized for the exact size, shape or location of the target tissue.

Features & Benefits

How Does SAVI Brachy Work?

SAVI Brachy - Step 1 - Placement

PLACEMENT

The SAVI Brachy applicator is gently inserted in a closed position into the tumor cavity through a small incision, a procedure that is usually done in the physician’s office.

SAVI Brachy - Step 2 - Expansion

EXPANSION

The catheters are gently expanded to conform to the shape of the cavity. This is done only once, at the beginning of treatment.

SAVI Brachy - Step 3 - Radiation Delivery

RADIATION DELIVERY

Once the catheter is in place, a radiation oncologist delivers treatment twice a day for 2-5 days. The ends of the catheters are connected to a computerized delivery system that painlessly delivers a tiny radioactive seed into each tube. The radiation source is completely removed after each treatment – no radiation remains in the body between treatments.

SAVI Brachy - Step 4 - Removal

REMOVAL

After the last radiation treatment, the physician will close the device and remove it through the same incision into which it was originally inserted.

CLINICAL DATA

FEATURED STUDY:
Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial

Overview of First Reported Results

200 patients enrolled August 2015 – August 2017

Int J Radiat Oncol Biol Phys. 2019;104(1):67-74. doi:10.1016/j.ijrobp.2018.12.050.

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Objectives & Goals

Primary Objective:
Toxicity @ 2 yrs

  • Goal: <10% serious toxicity rate* (Grade 3 or above)
  • Results: Grade 3 N=3 (1.5%) N=11 upper limit 

Secondary Objectives:
Cosmesis @ 2 yrs.

  • Goal: >80% good/excellent
  • Results: 97.25% good/excellent

Local control @ 3 yrs:

  • Goal: ≤5% recurrence
  • Results: 1% (Local control 99%)

Reported Conclusions

Ultrashort breast brachytherapy is dosimetrically feasible and can be delivered with excellent short-term tolerance and low toxicity.

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ADDITIONAL STUDIES

Case Review: Yashar (2019). SAVI Brachytherapy with TRIUMPH-T 2-day Treatment Regimen.
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Peer Reviewed: Wilkinson JB, Chen PY, Wallace MF, et al. (2018). Six-Year Results From a Phase I/II Trial for Hypofractionated Accelerated Partial Breast Irradiation Using a 2-Day Dose Schedule. Am J Clin Oncol. 2018;41(10):986-991. doi:10.1097/COC.0000000000000402
https://pubmed.ncbi.nlm.nih.gov/28787281/
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Peer Reviewed: Yashar C, Attai D, Butler E, et al. (2016). Strut-based accelerated partial breast irradiation: Report of treatment results for 250 consecutive patients at 5 years from a multicenter retrospective study. Brachytherapy. 2016;15(6):780-787. doi:10.1016/j.brachy.2016.07.002
https://pubmed.ncbi.nlm.nih.gov/27528591/
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Peer Reviewed: Rehman S, Agarwal R, Ochoa L, et al. (2016). Prospective analysis of toxicity in patients treated with strut-adjusted volume implant for early-stage breast cancer. Brachytherapy. 2016;15(5):625-630. doi:10.1016/j.brachy.2016.04.008
https://pubmed.ncbi.nlm.nih.gov/27263058/
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Peer Reviewed: Mooney KE, Altman MB, Edward S, et al. (2016). Accelerated partial breast irradiation dosimetric criteria for the strut-adjusted volume implant. Brachytherapy. 2016;15(5):616-624. doi:10.1016/j.brachy.2016.05.002
https://pubmed.ncbi.nlm.nih.gov/27349857/
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Strnad et al. (2015). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. 2016;387(10015):229-238, Jan 16, 2016. doi:https://doi.org/10.1016/S0140-6736(15)00471-7
https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00471-7/fulltext
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Looking for more? Find Pre-2015 studies here >>


CONSENSUS STATEMENTS

 

SAVI Brachy - Patient Selection Criteria - Merit MedicalPatient Selection Criteria PDF

Shah C, Vicini F, Shaitelman SF, et al. (2017). The American Brachytherapy Society consensus statement for accelerated partial-breast irradiation. Brachytherapy. 2018;17(1):154-170. doi:10.1016/j.brachy.2017.09.004 https://pubmed.ncbi.nlm.nih.gov/29074088/

The American Society of Breast Surgeons (2011). Consensus statement for accelerated partial breast irradiation. https://www.breastsurgeons.org/docs/statements/Consensus-Statement-for-Accelerated-Partial-Breast-Irradiation.pdf

American Society Radiation and Oncology (2016). Consensus Statement on Partial Breast Irradiation. https://www.practicalradonc.org/article/S1879-8500(16)30184-9/fulltext

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REFERENCES

  1. Gurdalli S, Kuske R, Quiet C. Dosimetric Comparison of Three Brachytherapy Applicators for Partial Breast Irradiation. Poster session presented at the World Congress of Brachytherapy, May 4-6, 2008.
  2. Khan AJ, Chen PY, Yashar C, et al. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial. Int J Radiat Oncol Biol Phys. 2019;104(1):67-74. doi:10.1016/j.ijrobp.2018.12.050
  3. Hannoun-Levi JM, Resch A, Gal J, et al. Accelerated partial breast irradiation with interstitial brachytherapy as second conservative treatment for ipsilateral breast tumour recurrence: multicentric study of the GEC-ESTRO Breast Cancer Working Group. Radiother Oncol. 2013;108(2):226-231. doi:10.1016/j.radonc.2013.03.026
  4. Yashar C, Scanderbeg D, et al. Initial Clinical Experience with the Strut-Adjusted Volume Implant (SAVI) Breast Brachytherapy Device for Accelerated Partial-Breast Irradiation (APBI): First 100 Patients with More than 1 Year of Follow Up. Int J Radiat Oncol Biol Phys. 2011 Jul 1; 80(3): 765-70.
  5. Van Limbergen E & Mazeron JJ. Breast Cancer. In Gerbaulet A, Pötter R, Mazeron J-J, Meertens H and Van Limbergen E (Eds).The GEC ESTRO Handbook of Brachytherapy. Leuven, Belgium, ACCO. 2002
  6. Vratislav Strnad, MD, Csaba Polgar, MD, et al. 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomized, phase 3, non-inferiority trial. GEC-ESTRO The Lancet, October 2015

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Catalog NumberExpanded Family NameApplicator SizeSizeRadiation SourceSterilizationLatex FreeShipping Box Qty
CP-01Catheter Protector SetNSYes1
ET-01Expansion ToolNSYes1
FR-10Foam Ring SetNSYes1
OB-01Blunt ObturatorGammaYes1
PREP-01SpacerGammaYes1
SAVI-06Applicator Tray6-1GammaYes1
SAVI-06GAMMAApplicator Tray6-1GammaGammaYes1
SAVI-06MINIApplicator Tray6-1MiniGammaYes1
SAVI-06MINIGAMMAApplicator Tray6-1MiniGammaGammaYes1
SAVI-08Applicator Tray8-1GammaYes1
SAVI-08GAMMAApplicator Tray8-1GammaGammaYes1
SAVI-10Applicator Tray10-1GammaYes1
SAVI-10GAMMAApplicator Tray10-1GammaGammaYes1
SPC-01Prep Catheter TrayGammaYes1
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