Elekta secures FDA clearance for Venezia cervical cancer treatment device

February 6, 2017 – 8:50 AM | By Andrea Gonzalez | No comments yet
By Omar Ford, Staff Writer

Elekta AB has received FDA clearance for its Venezia applicator for gynecological brachytherapy. The device is positioned to treat advanced-stage cervical cancer and has had a CE mark since last year.

The Stockholm-based company said Venezia has a design that facilitates predefined and consistent needle placement to access difficult to reach tumors that extend outside of the cervix.

Elekta said the use of interstitial brachytherapy in patients with tumors that extend outside of the cervix may be underutilized due to the limited reach of existing applicators and the complexity of precisely targeting tumor tissue.

Data from a published clinical study demonstrated that cervical cancer patients receiving a brachytherapy boost following external beam radiation therapy had 12 percent better overall survival at four years compared with patients receiving the therapy alone. Other studies have shown the use of 3-D image-guided brachytherapy using interstitial needles that expand the treatment area and conform to the shape of the tumor is associated with improved clinical outcomes, especially for patients with larger tumors.

Deanine Halliman, senior manager of medical affairs for Elekta said physicians have been clamoring for a solution like Venezia.

“There have been a lot of ‘homemade solutions’ to treat a lot of locally advanced cancers,” Halliman, told Medical Device Daily. “These devices might not give one as many reproducible results as they would like. Venezia really gives the radiation oncologist reproducible results and consistent results with each locally advanced cancer that they are able to treat.”

STILL ROOM FOR GROWTH

There has been a growing demand for radiotherapy platforms, leaving both Elekta and its competitor Palo Alto, Calif.-based Varian Medical Systems Inc. plenty of room to expand, said Alex Morozov, an analyst with Morning Star.

Morozov said the current market had roughly 5,000 linear accelerators, or linacs, and could support twice as many platforms without approaching the developed world’s standard of care.

“Our forecast calls for close to 95 percent of the world’s radiotherapy equipment installations to be provided by these two companies over the next decade,” Morozov said. “We expect Elekta to deliver high-single-digit top-line growth and double-digit earnings growth over the next decade, above the device industry averages.”

The firm has been making progress on this end. Just last week, Elekta executives said the company received an order from Uppsala University Hospital for its Versa Hd linear accelerators. Elekta said the center will acquire the Versa Hd and Flexitron brachytherapy afterloaders, which will be installed in Uppsala University Hospital’s new oncology building currently under construction.

The company is also in a high profile partnership with Amsterdam-based Royal Philips NV to develop an imaging-treatment platform that merges radiation therapy and MRI technology in a single treatment system.

The program for development will include a research consortium of radiation oncology centers and clinicians, which today includes the University Medical Center Utrecht. In addition, both Elekta and Philips have built and tested a prototype system that integrates a linear accelerator and a 1.5 Tesla MRI system.

Elekta’s competitor, Varian has been in the spotlight in recent months due to the spin off of its imaging business – which is now called Varex Imaging Corp. Last month, the unit successfully split from Varian. Prior to the separation, Varian picked up the medical imaging business of Waltham, Mass.-based Perkinelmer Inc. for $276 million to incorporate it into Varex Imaging Corp. (See Medical Device Daily, Dec. 23, 2016.)

Varian first announced the split in May 2016. (See Medical Device Daily, May 25, 2016.)

“The spinout makes Varian a more streamlined company focused exclusively on the treatment of cancer,” said Sean Lavin, an analyst with BTIG.

 

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