Novian Health has received the US Food and Drug Administration (FDA's) investigational device exemption (IDE) approval to commence a study of its Novilase interstitial laser therapy (ILT) system.
Novilase uses controlled heat to ablate malignant breast tumors.
Patients enrolled in the study will undergo Novilase ILT of a malignant breast tumor.
The procedure is carried out by using either ultrasound or stereotactic x-ray imaging guidance and two small 14-gauge probes.
The researchers will collect data to confirm the tumor has been destroyed and correlate the post-ablation imaging (i.e., MR, ultrasound, and x-ray) with pathology.
The multi-center, single-site feasibility study was conducted at Rush University Medical Center by Kambiz Dowlat.
Novian Health’s Scientific Advisory Board member and Rose Medical Center Cancer Committee chairwoman Barbara Schwartzberg said the potential benefit offered by Novilase has extended the treatment options for their patients in terms of non-surgical removal of non-malignant tumors.
Novian Health has also launched its American breast laser ablation therapy evaluation (ABLATE) to track the progress of women who receive Novilase Breast Therapy.