Medical Device Daily
A robot developed by a French start-up that guides an endoscope during minimally invasive surgeries has been approved by the U.S. FDA and was used for the first time in North America at the Fox Chase Cancer Center (Philadelphia) last month, for ablation of a tumor during a distal pancreatectomy.
In minimally invasive procedures surgeons need both hands to manipulate surgical tools and an assistant typically is required to maneuver the endoscope to provide a view of the surgical field.
The ViKY robotic laparoscope holder, developed by Endocontrol Medical (La Tronche, France), returns endoscope control to the surgeon who directs its movements either through voice recognition or a footswitch.
With a CE mark since May 2007, the ViKY robot has been used in more than 200 surgeries in Paris, at Pitié-Salpêtrière, the Institut Mutualiste Montsouris, the Centre Hôpitalière de Nanterre and the Clinique de Turin, at the Grenoble Hospital as well as at reference medical centers in Antwerp, Belgium, and Utrecht, the Netherlands.
Endocontrol reports that 15 ViKY systems have been sold so far to hospitals in Austria, Belgium, France, Holland, Ireland, Italy and Spain.
ViKY is the result of a six-year development effort at the Joseph Fourier University in Grenoble that culminated in a technology transfer from the TIMC-IMAG laboratories (Techniques for biomedical engineering and complexity management – informatics, mathematics and applications) run jointly with the National Center for Scientific Research (CNRS) to the nearby incubator complex Biopolis.
Researchers collaborated with surgeons from the urology and gastroenterology department at Grenoble University Hospital, adapting the technology to the demands of an operating theater by greatly reducing the footprint of the robot arm and controls to the size of an office lamp, and adding ergonomic features, significantly the Bluetooth headset used for voice recognition command of the robot's movements.
ViKY is placed directly on the patient's abdomen and is compatible with all types of endoscopes and trocars. A passive arm holds the motorized scope holder just above the patient abdomen and attaches to the rail of the operating table. The motorized scopeholder and features three degrees of movement, two rotational axes and a mechanical in-and-out zoom.
Another innovation with ViKY is an instrument-tracking system, a challenge for endoscopic procedures in a mass of soft and moveable tissue compared to successes for such systems in orthopedics or neuro surgeries that are performed in close proximity to hard and relatively stable landmarks of the skeletal structure.
Endocontrol was created in 2006 to bring the technology to market and said the FDA approval is vital to the company's growth plans, as the U.S. represents 40% of the global market for endoscopic robots.
Endocontrol, which introduced ViKY to the U.S. market in January at the Society of Thoracic Surgeons meeting in San Francisco, said it already has established a network of distributors for North America and has developed a close working relationship with the department of urology at the Cleveland Clinic.
The company said almost 60% of the 5.4 million laparoscopic surgeries performed annually in the U.S. are target surgeries and that 2.4 million targeted procedures are performed each year in Europe.
The company notes that 2004 estimates of 4.6% annual growth for these procedures have been "overwhelmed" by actual growth estimated now at upwards of 23% annually.
The ViKY robot can be used as an assistant for digestive and bariatric surgeries, complex urological laparoscopic procedures, gynecological surgeries, thoracic surgeries including coronary bypass and pulmonary procedures, as well as abdominal aorta aneurysm surgery.
ScyFIX treatment gets CE mark
A new treatment by ScyFIX (Minneapolis, Minnesota) that has been shown to delay and potentially reverse blindness has received CE-mark approval. The first-of-its-kind therapy uses microcurrent neuromodulation to help prevent vision loss and even restore sight for patients with low-vision blindness-related diseases. The company said this is the first-ever device therapy approval for retinitis pigmentosa (RP), a degenerative disease where peripheral vision is lost that can lead to total blindness.
Additional approvals for the treatment of other blindness-related diseases are expected soon, ScyFIX said.
The ScyFIX 700 works by administering a tiny current of electricity that stimulates the body's own healing capabilities. has developed the technology over the past seven years.
"The approval of this breakthrough therapy gives hope to the millions of people suffering from low-vision, blindness-causing diseases who have had no therapy options until now," said Thomas Harold, founder of ScyFIX and inventor of the ScyFIX 700. "Patients now report seeing faces of their family members, using mobile phones, reading newspapers and performing day-to-day tasks, which was not possible for them prior to use of the ScyFIX therapy."
The new therapy is immediately available for purchase with a prescription from an eye care professional in all countries that recognize CE mark.
RP affects more than 2 million people worldwide. Since it is degenerative, the condition will only worsen and can lead to total blindness. But in the study, the visual field – the actual amount the eyes can see – was either expanded or remained stable in 85% of patients and actually improved in 63%.
Spain distribution deal for PLC
PLC Systems (Franklin, Massachusetts) said it has entered into a five year exclusive agreement with IZASA Distribuciones Tecnicas (Barcelona, Spain) for distribution of its RenalGuard System into that country
PLC said IZASA is one of Spain' leading distributors of interventional cardiology-related medical devices, and a part of the Werfen Group. It will target early adopters who recognize the benefits of utilizing the fluid-balancing capabilities of PLC's RenalGuard in a cath lab setting during cardiovascular imaging procedures for patients at higher risk of contrast-induced nephropathy (CIN).
PLC President/CEO Mark Tauscher said, "We are ... pleased with our new agreement with IZASA in Spain. This firm's strong penetration of the leading cardiovascular centers in Spain will help expose the benefits of RenalGuard to a wider community of physicians."