Novian Health obtains CE Mark for Novilase Breast Therapy
advertisement
Current Location:
>
>
> This Story

Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

Women's Health Homepage

Margaret West Comprehensive Breast Center selects Ikonopedia for structured breast reporting and risk assessment

Imago Systems announces collaboration with Mayo Clinic for breast imaging

Hologic acquires approximately 46 percent of shares in SuperSonic Imagine

Densitas announces clinical advisory board

QTbreasthealth brings FDA-cleared technology for radiation-and compression-free breast imaging to Scottsdale

Ikonopedia showcases automated combined reporting package to be released at AHRA

Fujifilm announces release of Tomosynthesis Biopsy option for Aspire Cristalle mammography system

Volpara signs distribution agreement to sell Transpara, Screenpoint Medical's AI solution for breast cancer detection

MITA applauds Congressional effort urging coverage for dense breast tomosynethesis (DBT) screening for TRICARE beneficiaries

Fujifilm presents imaging portfolio for better patient experiences and outcomes at AHRA 2019

Novian Health obtains CE Mark for Novilase Breast Therapy

Press releases may be edited for formatting or style
CHICAGO, July 16, 2019 /PRNewswire/ -- Novian Health Inc. announced that it has obtained the CE Mark approval for its Novilase® Breast Therapy, a minimally invasive procedure that uses laser induced heat for focal destruction of breast tumors up to 2 centimeters (cm) in size. The CE Mark approval allows Novian Health to commercialize its technology in the European Union (EU) and Switzerland, giving women an alternative to surgery for early-stage breast cancer and benign breast tumors (fibroadenomas).

"The CE Mark is a significant milestone for Novian Health, as Novilase is the first thermal ablation device approved for treatment of malignant breast tumors," said Henry Appelbaum, president and CEO of Novian Health. "Laser therapy can help women to avoid the trauma and risks of surgery. We're thrilled to have the opportunity to bring this option to women in the EU."

Story Continues Below Advertisement

THE (LEADER) IN MEDICAL IMAGING TECHNOLOGY SINCE 1982. SALES-SERVICE-REPAIR

Special-Pricing Available on Medical Displays, Patient Monitors, Recorders, Printers, Media, Ultrasound Machines, and Cameras.This includes Top Brands such as SONY, BARCO, NDS, NEC, LG, EDAN, EIZO, ELO, FSN, PANASONIC, MITSUBISHI, OLYMPUS, & WIDE.



A minimally invasive procedure, Novilase Breast Therapy requires only local anesthesia. Two small probes are inserted into the breast and guided to the tumor by ultrasound imaging. One probe uses heat to destroy the tumor while the other monitors the procedure through temperature. The treatment takes less than 30 minutes and its success is confirmed by follow-up imaging.

A recent study conducted in the U.S. and U.K. showed that more than 90 percent of malignant breast tumors were completely destroyed during one Novilase procedure. In addition, patients in the trial reported better health-related quality of life outcomes compared to lumpectomy surgery. No serious adverse events were reported.

"Novilase represents a major paradigm shift in how we treat early-stage breast cancer, effectively replacing the traditional lumpectomy," said surgeon Barbara Schwartzberg, principal investigator of the Novilase study. "Using laser technology to treat breast tumors is less invasive, less painful, and produces better cosmetic results, in addition to being significantly less expensive. Compared to surgery, it's simply a better technique all around."

In the United States, Novilase has been cleared as an alternative to surgery for the treatment of fibroadenomas. The FDA approved an investigational device exemption (IDE) to conduct a confirmatory study (BR-003) to gather data to support a marketing application for focal destruction of malignant breast tumors. Investigators at U.S. and European sites will participate in the BR-003 study.

"I'm confident the existing data, combined with the results of the forthcoming BR-003 study, will be enough to support moving forward with laser ablation therapy for women with early-stage breast cancer in the United States," said Dr. Schwartzberg.
  Pages: 1 - 2 >>

Women's Health Homepage


You Must Be Logged In To Post A Comment