Targeted Accelerated Partial Breast Irradiation (APBI) in just 2-5 Days2 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.
TARGETING PRECISION
Minimizes dose to healthy tissues and critical structures while maximizing target coverage4
SHORTENED TREATMENT COURSE
Effective APBI in just 2-5 days2 offers greater convenience/fewer treatments
How SAVI Brachy Works
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.
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.
EXPANSION
The catheters are gently expanded to conform to the shape of the cavity. This is done only once, at the beginning of treatment.
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.
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.
DOCUMENTS
Discover more about SAVI Brachy by reviewing the full array of documents.
INSTRUCTIONS FOR USE
SAVI Applicator IFU
SAVI Blunt Obturator IFU
SAVI Prep Catheter IFU
SAVI Foam Rings IFU
CLINICAL DATA
Peer Reviewed: Khan AJ, Chen PY, Yashar C, et al. (2019). 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
https://pubmed.ncbi.nlm.nih.gov/30611839/
Preview
Case Review: Yashar (2019). SAVI Brachytherapy with TRIUMPH-T 2-day Treatment Regimen.
Download Case Study
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/
Preview
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/
Preview
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/
Preview
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/
Preview
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
Preview
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
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.
Earlier SAVI Publications
Peer Reviewed: Fisher B, Daugherty L, Shaikh T, et al. (2012) Tumor bed-to-skin distance using accelerated partial-breast irradiation with the strut-adjusted volume implant device. Brachytherapy. 2012;11(5):387-391. doi:10.1016/j.brachy.2011.09.009
https://pubmed.ncbi.nlm.nih.gov/22104353/
Peer Reviewed: Yashar CM, Scanderbeg D, Kuske R, et al. (2011) 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;80(3):765-770. doi:10.1016/j.ijrobp.2010.02.018
https://pubmed.ncbi.nlm.nih.gov/20646847/
Peer Reviewed: Scanderbeg D, Yashar C, White G, Rice R, Pawlicki T (2010) Evaluation of three APBI techniques under NSABP B-39 guidelines. J Appl Clin Med Phys. 2009;11(1):3021. Published 2009 Dec 3. doi:10.1120/jacmp.v11i1.3021
https://pubmed.ncbi.nlm.nih.gov/20160680/
Peer Reviewed: Manoharan, Sivasubramanian R et al. (2010) Dosimetry evaluation of SAVI-based HDR brachytherapy for partial breast irradiation. Journal of medical physics vol. 35,3 (2010): 131-6. doi:10.4103/0971-6203.62127
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2936181/
Peer Reviewed: Bloom ES, Kirsner S, Mason BE, et al. (2010) Accelerated partial breast irradiation using the strut-adjusted volume implant single-entry hybrid catheter in brachytherapy for breast cancer in the setting of breast augmentation. Brachytherapy. 2011;10(3):178-183. doi:10.1016/j.brachy.2010.06.008
https://pubmed.ncbi.nlm.nih.gov/20719576/
Peer Reviewed: Gurdalli S, Kuske RR, Quiet CA, Ozer M. (2010) Dosimetric performance of Strut-Adjusted Volume Implant: a new single-entry multicatheter breast brachytherapy applicator. Brachytherapy. 2011;10(2):128-135. doi:10.1016/j.brachy.2010.03.002
https://pubmed.ncbi.nlm.nih.gov/20817617/
Peer Reviewed: Scanderbeg D, Yashar C, Rice R, Pawlicki T (2009) Clinical implementation of a new HDR brachytherapy device for partial breast irradiation. Radiotherapy and Oncology. 2009;90(1):36-42.
doi.org/10.1016/j.radonc.2008.09.024.
https://www.sciencedirect.com/science/article/abs/pii/S016781400800515X
Earlier APBI Publications
Peer Reviewed: Smith GL, Xu Y, Buchholz TA, et al. (2012) Association between treatment with brachytherapy vs whole-breast irradiation and subsequent mastectomy, complications, and survival among older women with invasive breast cancer. JAMA. 2012;307(17):1827-1837. doi:10.1001/jama.2012.3481
https://pubmed.ncbi.nlm.nih.gov/22550197/
Peer Reviewed: Presley CJ, Soulos PR, Herrin J, et al. (2012) Patterns of use and short-term complications of breast brachytherapy in the national medicare population from 2008-2009. J Clin Oncol. 2012;30(35):4302-4307. doi:10.1200/JCO.2012.43.5297
https://pubmed.ncbi.nlm.nih.gov/23091103/
Peer Reviewed: Hepel JT, Wazer DE. (2012) A comparison of brachytherapy techniques for partial breast irradiation. Brachytherapy. 2012;11(3):163-175. doi:10.1016/j.brachy.2011.06.001
https://pubmed.ncbi.nlm.nih.gov/21816686/
Peer Reviewed: Hoopes DJ, Kaziska D, Chapin P, et al. (2012) Patient preferences and physician practice patterns regarding breast radiotherapy. Int J Radiat Oncol Biol Phys. 2012;82(2):674-681. doi:10.1016/j.ijrobp.2010.11.077
Guinot, J.L., Tortajada, M.I., Carrascosa, M. et al. (2011) Ten-year results of a phase II study with a single fraction of high-dose-rate brachytherapy (FAST-boost) after whole breast irradiation in invasive breast carcinoma. Clin Transl Oncol 14, 109–115 (2012). https://doi.org/10.1007/s12094-012-0769-3
https://link.springer.com/article/10.1007/s12094-012-0769-3
Jona A. Hattangadi, Nathan Taback, Bridget A. Neville, Jay R. Harris, Rinaa S. Punglia (2011) Accelerated Partial Breast Irradiation Using Brachytherapy for Breast Cancer: Patterns in Utilization and Guideline Concordance, JNCI: Journal of the National Cancer Institute, Volume 104, Issue 1, 4 January 2012, Pages 29–41
https://doi.org/10.1093/jnci/djr495
Ojeda-Fournier H, Olson L, Rochelle M, Hodgens B, Tong E, Yashar C (2011) Accelerated Partial Breast Irradiation and Posttreatment Imaging Evaluation. RadioGraphics 2011; 31:1701–1716.
https://pubs.rsna.org/doi/pdf/10.1148/rg.316115517
Holmes, D.R. (2011) Ongoing Consideration of Cavity Evaluation Devices in the Treatment of Breast Cancer. Ann Surg Oncol 18, 1809 (2011).
https://doi.org/10.1245/s10434-011-1684-5
Peer Reviewed: Kuske R, Zannis V. (2011) Spacer balloons prior to partial breast irradiation: helpful or hurtful?. Ann Surg Oncol. 2011;18(7):1807-1808. doi:10.1245/s10434-011-1682-7
https://pubmed.ncbi.nlm.nih.gov/21487967/
Shah, et al. (2011) Twelve-year clinical outcomes and patterns of failure with accelerated partial breast irradiation versus whole-breast irradiation: Results of a matched-pair analysis. 2011;100(2):210-214. doi.org/10.1016/j.radonc.2011.03.011
https://www.sciencedirect.com/science/article/abs/pii/S0167814011001332
Peer Reviewed: Smith GL, Xu Y, Buchholz TA, et al. (2011) Brachytherapy for accelerated partial-breast irradiation: a rapidly emerging technology in breast cancer care. J Clin Oncol. 2011;29(2):157-165. doi:10.1200/JCO.2009.27.0942
https://pubmed.ncbi.nlm.nih.gov/21135274/
Peer Reviewed: Njeh CF, Saunders MW, Langton CM. (2010) Accelerated Partial Breast Irradiation (APBI): A review of available techniques. Radiat Oncol. 2010;5:90. Published 2010 Oct 4. doi:10.1186/1748-717X-5-90
https://pubmed.ncbi.nlm.nih.gov/20920346/
Peer Reviewed: Patel RR, Christensen ME, Hodge CW, Adkison JB, Das RK. (2008) Clinical outcome analysis in “high-risk” versus “low-risk” patients eligible for national surgical adjuvant breast and bowel B-39/radiation therapy oncology group 0413 trial: five-year results. Int J Radiat Oncol Biol Phys. 2008;70(4):970-973. doi:10.1016/j.ijrobp.2007.12.005
https://pubmed.ncbi.nm.nih.gov/18313521/
Kaufman S, et al. (2007) Long-term outcome and toxicity in a Phase I/II trial using high-dose-rate multicatheter interstitial brachytherapy for T1/T2 breast cancer. Brachytherapy. 2007;6(4):286-292
https://www.sciencedirect.com/science/article/abs/pii/S1538472107002504
Polgar C, et al. (2007) Breast-Conserving Treatment With Partial or Whole Breast Irradiation for Low-Risk Invasive Breast Carcinoma—5-Year Results of a Randomized Trial. Int. J. Radiation Oncology Biol. Phys., Vol. 69, No. 3, pp. 694–702.
https://doi.org/10.1016/j.ijrobp.2007.04.022
Peer Reviewed: Chen PY, Vicini FA, Benitez P, et al. Long-term cosmetic results and toxicity after accelerated partial-breast irradiation: a method of radiation delivery by interstitial brachytherapy for the treatment of early-stage breast carcinoma. Cancer. 2006;106(5):991-999. doi:10.1002/cncr.21681
https://pubmed.ncbi.nlm.nih.gov/16421922/
Peer Reviewed: Arthur DW, Vicini FA (2005) Accelerated partial breast irradiation as a part of breast conservation therapy. J Clin Oncol. 2005;23(8):1726-1735. doi:10.1200/JCO.2005.09.045
https://pubmed.ncbi.nlm.nih.gov/15755981/
ORDER INFORMATION
| Catalog Number | Expanded Family Name | Applicator Size | Size | Radiation Source | Sterilization | Latex Free | Shipping Box Qty |
|---|---|---|---|---|---|---|---|
| CP-01 | Catheter Protector Set | NS | Yes | 1 | |||
| ET-01 | Expansion Tool | NS | Yes | 1 | |||
| FR-10 | Foam Ring Set | NS | Yes | 1 | |||
| OB-01 | Blunt Obturator | Gamma | Yes | 1 | |||
| PREP-01 | Spacer | Gamma | Yes | 1 | |||
| SAVI-06 | Applicator Tray | 6-1 | Gamma | Yes | 1 | ||
| SAVI-06GAMMA | Applicator Tray | 6-1 | Gamma | Gamma | Yes | 1 | |
| SAVI-06MINI | Applicator Tray | 6-1 | Mini | Gamma | Yes | 1 | |
| SAVI-06MINIGAMMA | Applicator Tray | 6-1 | Mini | Gamma | Gamma | Yes | 1 |
| SAVI-08 | Applicator Tray | 8-1 | Gamma | Yes | 1 | ||
| SAVI-08GAMMA | Applicator Tray | 8-1 | Gamma | Gamma | Yes | 1 | |
| SAVI-10 | Applicator Tray | 10-1 | Gamma | Yes | 1 | ||
| SAVI-10GAMMA | Applicator Tray | 10-1 | Gamma | Gamma | Yes | 1 | |
| SPC-01 | Prep Catheter Tray | Gamma | Yes | 1 |
Consensus Statements
Patient 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
COVID-Specific Support Materials
Related
Customer Implementation Resources
SAVI Brachy Education
The Latest in SAVI APBI
References
- 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.
- 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
- 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
- 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.
- 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
- 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
Current IFUs
Current Brochures
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| Catalog Number | Expanded Family Name | Applicator Size | Size | Radiation Source | Sterilization | Latex Free | Shipping Box Qty |
|---|---|---|---|---|---|---|---|
| CP-01 | Catheter Protector Set | NS | Yes | 1 | |||
| ET-01 | Expansion Tool | NS | Yes | 1 | |||
| FR-10 | Foam Ring Set | NS | Yes | 1 | |||
| OB-01 | Blunt Obturator | Gamma | Yes | 1 | |||
| PREP-01 | Spacer | Gamma | Yes | 1 | |||
| SAVI-06 | Applicator Tray | 6-1 | Gamma | Yes | 1 | ||
| SAVI-06GAMMA | Applicator Tray | 6-1 | Gamma | Gamma | Yes | 1 | |
| SAVI-06MINI | Applicator Tray | 6-1 | Mini | Gamma | Yes | 1 | |
| SAVI-06MINIGAMMA | Applicator Tray | 6-1 | Mini | Gamma | Gamma | Yes | 1 |
| SAVI-08 | Applicator Tray | 8-1 | Gamma | Yes | 1 | ||
| SAVI-08GAMMA | Applicator Tray | 8-1 | Gamma | Gamma | Yes | 1 | |
| SAVI-10 | Applicator Tray | 10-1 | Gamma | Yes | 1 | ||
| SAVI-10GAMMA | Applicator Tray | 10-1 | Gamma | Gamma | Yes | 1 | |
| SPC-01 | Prep Catheter Tray | Gamma | Yes | 1 |
