Novilase® Breast Therapy

    

MEDICAL PROFESSIONALS

Who May Benefit from Novilase?

Novilase Breast Therapy is intended for the treatment of fibroadenomas of the breast, for tumors up to 2.0 cm in size. Novilase is currently being evaluated in international multi-center clinical trials as a treatment for small breast cancers.

  • Enables physicians experienced in image guided biopsies 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 between the ages of 18 to 80 years old
  • 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 2.0 cm 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 Registry Candidates: Patients may be candidates for treatment if they have a fibroadenoma (benign breast tumor) according to the following criteria. Full inclusion/exclusion criteria for the registry may be found at ClinicalTrials.gov:

  • 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 offers the following advantages over lumpectomy.

  • Alternative to surgery or watching and waiting.
  • Minimally invasive choice with two small needle probes inserted via two skin nicks of about 1/8 inch each, versus the 2-3-inch incision needed for a lumpectomy.
  • Less infection risk because Novilase works through heating without an incision.
  • The Novilase Breast Therapy can be performed in an outpatient setting. Patients can resume normal activity within hours, and have a faster recovery period compared to surgery.
  • No stitches and minimal scarring. When the procedure is complete, the two small nicks are covered with a small adhesive bandage. A lumpectomy incision is closed with sutures and creates a more substantial scar.
  • Natural shape maintained. The “dimpling” that can occur with lumpectomy does not typically occur with Novilase, because the procedure does not remove tissue and can reduce any need for cosmetic reconstruction surgery.
  • Does not preclude other treatment options
  • Patients report high satisfaction

NOVILASE vs. LUMPECTOMY

Setting NOVILASE Lumpectomy
Office or Outpatient Operating Room
Anesthesia Local General / IV sedation
Entry Nicks (2 @ 1/8 inch) Incision (2-3 inches)
Tissue Removal No Yes
Scarring Minimal Yes
Closure Small Bandage Sutures
Recovery Same Day Several days

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