It's very common to hear a med-tech company mention a "global" solution.
But to pin down what is meant by a global solution is sometimes a tad difficult.
There is no question however, about what the g-word means when it comes to a new registry aimed at tracking the progress of the USHIFU's (Charlotte, North Carolina) Sonablate 500, a prostate cancer therapy that uses ultrasound.
The Sonablate International High-Intensity Focused Ultrasound (HIFU) Registry is expected to contain information on nearly 6,000 patients across the U.S. and around the globe who have been treated with the device a feat the company touts as a first.
It doesn't get any clearer than that, according to representatives from USHIFU.
"To my knowledge this registry is the first of its kind in a global sense," Amanda Willis, a spokeswoman for USHIFU told Medical Device Daily on Thursday. "From (USHIFU's) perspective, this registry will give participating physicians all across the world larger sets of data to draw from."
While there have been other device registries, this marks the first to incorporate data from outside as well as inside the U.S., Willis said.
The database was established by USHIFU along with Misonix (Farmingdale, New York) and Takai Hospital Supply (Tokyo) to offer what all parties are calling a single, secure, standardized repository of treatment information for those users.
"The Sonablate International HIFU Registry was created to capture the 'real life' practice of prostate cancer treatment, which for the most part fell outside the responsibility of clinical trials," said Rowland Illing of the Clinical Effectiveness Unit at the Royal College of Surgeons of England. "Sponsorship of this registry by the worldwide distribution partners of the Sonablate demonstrates their high level of confidence in the technology. The SIHR will be an incredibly powerful tool for continuing medical education, as it will allow the identification and dissemination of best practice. It will also provide a comprehensive international dataset with which to assess the determinants of outcome."
A key point with those involved is that the information gathered will be reviewed and analyzed by independent, third-party statisticians. According to Willis, at no point will the sponsoring organizations have access to the raw dataset.
Registry oversight will be provided by a steering committee consisting of senior Sonablate HIFU users from five different countries.
"The real value of having an independent, third party is so you minimize the risk of the data being bias and really create a platform above [scrutiny]," Willis said.
For the uninitiated, Sonablate uses soundwaves that are focused in a particular point of the prostate to destroy cancerous tissue. HIFU has the potential to achieve this by virtue of the size of the target lesion that it creates.
HIFU works by focusing a pulse of high-energy ultrasound waves onto single location about the size of a grain of rice.
The delivery of this energy to such a small area results in an increase in temperature to a point where the lipids (fats) in the cell membrane melt.
A reproducible but small volume of tissue destruction occurs. The distribution of these target lesions is under the control of the physician. During, the planning phase of the treatment, ultrasound is used to delineate the prostate in two dimensions.
Targeting can be planned in order to avoid the urinary sphincter, rectum, and possibly the neurovascular bundles (since preservation of these may preserve erectile function).
Once the treatment plan is established, the treatment is both driven and monitored by a computer program within the HIFU delivery system.
"It probably takes about three hours to complete the procedure," Willis said.
The Sonablate 500 was developed by FSI and is manufactured by Misonix, which also holds distribution rights in Europe. Takai Hospital Supply and THS International distribute the device in Southeast Asia and the Middle East.
The device has yet to receive FDA approval. However, it received the European CE mark in 2001 and has been used extensively in Canada.
It remains in two clinical trials in the U.S. — one for treatment of prostate cancer against brachytherapy, and the other for treatment of a recurring cancer after radiation.
The company was hesitant to comment on an estimated date of when the device would be commercially available in the U.S.
USHIFU is a healthcare development company and medical device distributor focused on creating a new standard for prostate cancer treatment with HIFU therapy.