A Medical Device Daily

Coronis (Montpellier, France), a supplier of ultra-low-power and long-range wireless solutions, said that its Wavenis technology has been integrated into new products by Data Health System (DHS; N mes, France) that automatically detect when people fall.

Initially targeted for use in retirement homes, the Ynolis product line includes “detection bracelets” connected to a central alarm unit via an ultra-low-power and long-range wireless network based on Wavenis technology.

When a person equipped with an Ynolis bracelet falls, the bracelet automatically sends an alarm to a central unit, which then relays it immediately to attendants' pagers for quick reaction. A main innovation in Ynolis is its ability to reliably discern the detection criteria that define a fall.

Wavenis wireless technology offers very-long-range communications with the lowest possible power consumption. It is optimized for battery-powered devices requiring extensive autonomy. Under equivalent operating conditions, other standard technologies reach 30 to 60 feet, while Wavenis reaches over 650 feet. This makes it possible to deploy very lightweight network infrastructure, frequently without repeaters.

Ynolis is being launched after several months of testing at the Montpellier University Hospital and the City of Paris Center for Social Action. DHS is currently selling Ynolis directly to retirement homes for a price of about around $1 per day.

The company also is in the process of negotiating agreements with medical product distributors in France and internationally.

“After rigorously evaluating a number of solutions, Wavenis technology from Coronis clearly stood out as the performance choice,” said Dr. Charles-Antoine Roussy, CEO and founder of Data Health System. “Today Wavenis offers the best price-performance ratio on the market. With it, Ynolis can reach several hundred [feet] and offer a battery life of several months.”

With sophisticated wireless techniques and Frequency Hopping Spread Spectrum (FHSS) in license-free 870 MHz (Europe) and 915 MHz (North America) bands, Wavenis technology combines long range and ultra-low power consumption. It is robust against physical and electrical interference while co-existing in harmony with other wireless technologies, including those operating in 2.4 GHz bands.

The fall-detection solution in Ynolis will soon be integrated, along with Wavenis, into a wristwatch with Swiss design and technology. The new design will be available for people at home starting in 2007.

UK hospital adds Sonablate device

Misonix (Farmingdale, New York) reported that North Bristol NHS Trust's Southmead Hospital has joined the list of hospitals and medical centers using the Sonablate 500 for high-intensity focused ultrasound (HIFU) treatment of prostate cancer on a fee-per-use basis.

The Sonablate 500 is a device developed by Focus Surgery (Indianapolis) and manufactured and distributed in Europe by Misonix. In the UK, the device is marketed through Misonix subsidiary UK-HIFU Ltd.

The fee-per-use program for the Sonablate 500 was launched in early 2006 and is available in 40 sites. Previously, the device had only been available in the UK for capital equipment purchases.

Southmead Hospital's Bristol Urology Unit will use the HIFU product for non-invasive treatment of prostate cancer. Many doctors are showing interest in the device because of its ability to deliver highly targeted treatment that generally does not require a second procedure for transurethral resection of the prostate.

“We believe healthcare providers using the Sonablate 500 have selected our device among the other alternatives because of its efficacy and its single-procedure treatment that is both sensitive to the patient's lifestyle as well as ongoing efforts by regulators, insurers and medical practitioners to control the cost of healthcare,” said Michael McManus Jr., president and CEO of Misonix. “Our device has the ability to destroy the cancerous tissue and at the same time preserve the vital structures around the gland.”

He said the Sonablate “has led to very positive outcomes for the treatment of more than 100 men with prostate cancer in the UK during the last 12 months alone. In recent months, we have been successful in bringing the device to significantly more medical facilities on a fee-per-use basis, thus enabling the treatment of many more men diagnosed with prostate cancer.”

In April, Misonix said that it had taken a majority interest in UK-HIFU as a part of the company's strategic commitment to expand its HIFU operations in Europe. It said a key initiative in the UK is close collaboration with leading healthcare providers, principally through the development of relationships with various trusts within the National Health Service system.

UK office for Vidacare

Vidacare (San Antonio), manufacturer of the EZ-IO Product System, a solution for immediate vascular access when conventional IV access is challenging or impossible, has opened its first international office in the UK. The new office, operating as Vidacare (UK) Ltd. (Heathfield) will serve as the hub for EZ-IO Product System sales to hospitals and emergency medical services throughout the UK.

Intraosseous (IO) infusion provides a direct conduit to the bloodstream through the bone, and is gaining widespread acceptance as an alternate route to administer IV drugs and fluids. Vidacare's lithium battery-powered EZ-IO drivers and needle sets offer healthcare providers an IO option that is stable and secure, delivering needed fluids and drugs to patients in just seconds.

The company said up to 25% of heart attack or cardiac arrest victims in the UK arrive at Accident & Emergency departments without viable IV access.

Diane Sweeney, an experienced critical-care nurse manager and medical device marketing professional whose career spans more than two decades, will serve as the country manager for Vidacare (UK) Ltd.

FDA okays Leksell GammaPlan PFX

Elekta (Stockholm, Sweden) reported FDA 510(k) pre-market clearance for Leksell GammaPlan PFX, the treatment-planning system developed for Leksell Gamma Knife Perfexion.

Elekta is expanding its Leksell Gamma Knife product line with a new stereotactic radiosurgery system that provides a radiosurgical platform for further refinement and expansion of procedures in the brain, cervical spine and head and neck regions. Leksell Gamma Knife Perfexion is pending 510(k) clearance from the FDA.