Who May Benefit from Novilase?
In the USA, Novilase Breast Therapy is intended for the treatment of fibroadenomas of the breast, for tumors up to 20 mm in size. Novilase is currently being evaluated in international multi-center clinical trials for focal destruction of small breast cancers ≤15 mm in size.
In Europe and the UK, Novilase is intended for the focal destruction of malignant and benign breast tumors ≤20 mm in size.
- Physicians experienced in image guided breast biopsies may utilize Novilase as an alternative to surgery to treat tumors in a minimally invasive manner.
- Physician utilizes image guided probe placement to target the specific treatment zone
- System provides real-time monitoring and control of laser ablation to ensure desired outcome
- System consists of a Class IV laser source in a mobile cart, disposable laser and thermal probes and proprietary treatment software
Cancer Trial Candidates: Patients may be candidates for the breast cancer clinical trial who generally fit the following criteria. Full inclusion/exclusion criteria for the clinical trial may be found at ClinicalTrials.gov:
- Females 18 years of age or older
- Breast tumor(s) detected by physical examination or by imaging such as mammogram, ultrasound, x-ray
- Tumor(s) must be well defined on a mammogram or ultrasound
- Tumor(s) that do not exceed 15 mm in diameter and measure at least 0.5 cm away from the skin and chest wall could be considered for treatment
- Complete a Breast MRI to confirm actual tumor size
- Definitive pathologic diagnoses by needle core biopsy indicating cancer
- Have not had reoccurring breast cancer
Benign Tumor Candidates: Patients may be candidates for treatment if they have a fibroadenoma (benign breast tumor) according to the following criteria.
- Patient is 18 years of age or older
- Benign diagnosis confirmed by needle core biopsy
- Tumor(s) detected by physical examination or imaging such as mammogram, ultrasound, or x-ray
- Tumor(s) is well visualized on ultrasound or x-ray
- Tumor(s) that do not exceed 2.0 cm in diameter and measure at least 0.5 cm away from the skin and chest wall could be considered for treatment
- Women with single, multiple, and/or bilateral benign breast tumors
- Patient has given consent prior to being treated with Novilase
Novilase Breast Therapy is NOT indicated for patients with the following criteria:
- Patient(s) under 18 years of age
- Patient(s) who are pregnant, breast feeding, lactating
- Patient(s) with uncorrectable coagulopathy
- Tumor(s) that cannot be clearly visualized with Breast MRI, mammography, ultrasound
- Tumor(s) with equivocal histology, i.e. cystosarcoma, hypercellularity suggestive of phyllodes, atypia, or in-situ carcinoma
- Tumor(s) with equivocal pathology report (e.g. discordance between radiographic and microscopic results)
- Tumor(s) fibroadenomas with stromal solidarity
Novilase Compared to Lumpectomy
Novilase Breast Therapy provides patients with both malignant and benign breast tumors a less invasive alternative to traditional surgery, offering numerous benefits:
- It serves as an alternative to the commonly recommended “watching and waiting” approach for benign breast tumors, significantly reducing anxiety.
- The procedure involves making two minor skin nicks, each approximately 1/8 inch in size, as opposed to the 2-3-inch incision required for a lumpectomy.
- There is a lower risk of infection compared to surgical procedures.
- Patients can quickly resume their daily activities within hours instead of the days required for recovery after surgery.
- The procedure does not require stitches and leaves minimal scarring. After completion, the two minor nicks are covered with a small adhesive bandage.
- The natural shape of the breast is preserved. Unlike lumpectomy, Novilase typically does not cause “dimpling” in the breast, as it does not involve tissue removal, reducing the need for cosmetic reconstruction surgery. The body naturally resorbs and remodels the ablated tissue.
- For malignant breast tumors, a Novilase procedure does not rule out the possibility of using other treatments, such as radiation or adjuvant therapies.
- Patients express high satisfaction with the procedure and their cosmetic outcomes.
NOVILASE vs. LUMPECTOMY
|Office or Outpatient||Operating Room|
|Anesthesia||Local||General / IV sedation|
|Entry||Nicks (2 @ 1/8 inch)||Incision (2-3 inches)|
|Recovery||Same Day||Several days|