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SAVI® Brachy

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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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

Peer Reviewed: L.E. Simon et al. (2022). Retrospective review of three-fractioned accelerated partial breast irradiation, Brachytherapy, https://doi.org/10.1016/j.brachy.2022.02.002
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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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COVID-SPECIFIC SUPPORT MATERIALS

 

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SAVI Brachytherapy - Minimizing Patient Contact Interactions During COVID-19 Infographic

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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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Documents

Discover more about SAVI Brachy by reviewing the brochures and Instructions for Use.

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