VIENNA, Austria — Don't say HIFU, please just say it is non-invasive treatment of uterine fibroids.

Like any industry, radiology is an alphabet soup of acronyms with major imaging modalities promoted as MRI, US and CT, with contrast enhancement adding to the mix for marketing materials touting CE-CT or CE-US, and even emerging metabolic imaging crossing over from nuclear medicine quickly creating SPECT or PET-MRI.

So why not put the short-hand reference 'HIFU-MRI' boldly into marketing materials, rather than buried in the plain text, while the headlines tout the long-winded and generic euphemism 'non-invasive treatment'?

No doubt it is the checkered past of high-intensity focused ultrasound (HIFU) that makes marketing people reluctant to broadcast the company's association with this emerging technology for treating tumors.

One of the most widespread applications for HIFU up to now, for example, has been ultrasound-assisted lipoplasty systems, or fat burning, and other office-based cosmetic surgery, which suggests something of a dodgy character to medical center clinicians.

Up to now a solid market opportunity for HIFU applications has not emerged, despite sales that had grown to $100 million worldwide by 2006, because the technology has developed unevenly and is spread across selected geographies according to regulatory approvals, reimbursement and clinical acceptance.

In Europe, for example, prostate-ablation systems are sold, while in the United States the Food and Drug Administration (FDA) cleared devices for uterine fibroid treatment in 2004 though low reimbursement has frustrated the development of this market.

The opportunity is enormous as uterine fibroids are the most common non-cancerous tumors in women of childbearing age and up to 20% of women with uterine fibroids experience severe symptoms that require treatment.

At ECR 2010 Royal Philips Electronics (Amsterdam, the Netherlands) entered the market introducing the Sonalleve MR-HIFU that offers three-dimensional planning for the intervention and real-time monitoring of temperature and tissue effects.

Thomas Andreae, Director of MR Marketing for Philips' Emerging Systems and Therapy (Vantaa, Finland) unit said the company believes the addition of a second major competitor in the uterine fibroid market could clear the path for a robust, upward growth in sales, he said.

“And it is a newer, superior technology with significantly faster ablation to reduce the requirement for MRI time, as well as unique volumetric heating and monitoring capabilities that we expect will win greater clinical confidence,“ he added.

The obstacle for HIFU, that blocks an open-field run into the massive markets for uterine fibroid and prostate cancer therapy, is a regulatory insistence on imaging guidance to monitor the effects of the high heat generated during the treatment.

Not convinced by the merits of ultrasound for monitoring effects, which likely will change with the emergence of tissue characterization using shear wave ultrasound, both the FDA and European authorities have insisted on guidance by MRI.

The added expense of MRI exams quickly leveled the economic arguments for HIFU against other treatments, such as hysterectomy and myomectomy, which typically also require the necessary expense of hospital stays.

GE Healthcare (Little Chalfont, UK) has struggled against low outpatient reimbursement rates for the ExAblate HIFU-MRI that have stymied sales since its introduction in 2005.

In the key U.S. market, payment rates of $1,700 to $2,600 set for other minimally invasive uterine fibroid treatments, such as uterine artery embolization, hardly begin to cover the MRI-related costs that are estimated to be between $7,000 and $8,500 per treatment.

The ExAblate HIFU-MRI system is produced by InSightec (Tirat Carmel, Israel/Dallas) from GE technology transferred to the Israeli company's majority shareholder, Elbit Technology (Dallas).

GE has a 21% interest in InSightec.

The ExAblate table docks to the GE Signa HD 1.5T, as well as GE 3.0 Tesla machines since 2007.

The company says that more than 4,500 women have been treated with ExAblate since it was brought into the clinic in 2006.

In March 2009 InSightec raised $15 million from its existing investors to further develop the technology and begin clinical trails for a wider number of cancer indications

The firm expects to begin a trial in 2010 for palliative treatment of bone metastases, a treatment for which it received the CE mark in June 2007.

Uterine fibroid ablation becomes a two-hour procedure, with much of this time taken up by the MRI scanning, and is performed on an outpatient basis with the patient typically returning to normal function within two days.

As with the ExAblate system, the Philips' Sonalleve MR-HIFU is built into a gurney, charmingly referred to as a trolley in European English, so that an MRI scanner does not need to be dedicated to the procedure and can be used for other routine examinations.

Sonalleve MR-HIFU, which received CE mark for clinical use in December, 2009, can be used with either the 1.5 Tesla or 3.0 Tesla versions of the Philips Achieva MRI scanners, as well as the company's Intera low-end scanner and the Panorama open platform MRI.

The HIFU transducer is integrated into the underside of the gurney thanks to a circle cut into the middle of the table top to expose the parabolic face of the HIFU transducer against the patient's abdomen.

A shield is strapped onto the back of the patients that houses the Philips' SENSE Pelvis coil as well as the sensors for temperature monitoring.

Philips' HIFU-MR leader Andreae explains that the focal point of HIFU creates a lesion the size of a rice grain and the Sonalleve planning software can be used to design a point-by-point targeting that moves to different areas during treatment to reduce over-heating of tissue in one region.

This mobile targeting creates a challenge, he said, because the fibroids are a fairly large target and the procedure could take between three and five hours.

A second problem with HIFU is focusing a fixed energy that heats irregularly which can result in uneven ablation of the region of interest, depending on the tissue type.

Philips solution to these problems on the Sonalleve MR-HIFU is volumetric heating where the focal beam is guided in a circular pattern covering a range from 4 mm to 16 mm in a 90-second bursts, and then thermal feedback in real time.

The actual time of the applied HIFU therapy is under 10 minutes, he said, and far less with experienced operators.

Philips installed 16 first-generation Sonalleve MR-HIFU units by the end of 2009 as investigative devices to compile a clinical experience.

Clinical experience to date is based on a study with 50 patients treated at six sites in Europe, the U.S. and Asia.

The study demonstrates the faster treatment times, which could lower the expense, and validated the ablation of large volumes.

The first generation investigative units are now being upgraded to next-generation capabilities of the commercial version and are increasingly being used in routine practice, he said.

Philips is following GE in indications for bone metastases and other cancers including breast, prostate and liver lesions.

Philips is also investigating applications for Sonalleve MR-HIFU for temperature triggered release of pharmaceutical therapies in a partnership with Celsion (Columbia, Maryland), as well as applications for molecular imaging in targeted gene therapy by temperature controlled gene expression.