St. Jude Medical Inc. (NYSE:STJ) announced a med-tech first with a European CE Mark approval for its Genesis implanted neurostimulation device for patients with chronic migraines.
Genesis, which is the first device of its kind to win regulatory approval in any market, provides peripheral nerve stimulation to the occipital nerves to manage migraines. Small electrical leads are placed under the skin and connected to a device which produces pulses of stimulation.
St. Jude’s PNS evaluation study, the largest clinical study evaluating PNS as a treatment for chronic migraine, found that 65 percent of patients reported excellent or good pain relief at one year and 88 percent said they would require the procedure to a friend.
"Through my participation in this study, I have observed the life-changing potential this therapy offers chronic migraine patients," principle investigator Dr. Stephen Silberstein said in prepared remarks.
"For more than six years we have worked with our investigators to develop and evaluate this life-changing therapy," St. Jude neuromodulation division Chris Chavez said in the press release. "We will continue to work with regulatory authorities to secure approvals in order to offer this therapy option to patients throughout the world."
The St. Paul, Minn.-based company touted a second regulatory win and industry first with Indian approval of its Quadra CRT-D quadripolar pacing system for cardiac resynchronization therapy defibrillators.
The device allows physicians to address pacing complications without surgically repositioning a CRT lead. Quadra uses four electrodes that can form 10 pacing configurations so doctors can pace around scar tissue and avoid other common CRT complications, according to a press release.
Mela Sciences (NSDQ:MELA) touted CE Mark approval in the European Union for its flagship MelaFind melanoma detection device, which has languished in FDA review purgatory since signing a binding agreement with the watchdog agency before conducting clinical trials.
Shares jumped 66 percent to $3.74 in afternoon trading on news of the regulatory win, after closing at $2.24 yesterday. That hardly makes up for the dramatic drop in share price that came after the FDA released documents in November 2010 arguing that MelaFind might to more harm than good by discouraging proper biopsies.
Shares were trading around $7.00 prior to the announcement, and promptly sank below $3.00 in the days after the FDA release.
The MelaFind instrument uses a computer-controlled multi-spectral dermoscope, employing light to image the skin through a thin layer of liquid (alcohol or oil), making lesion structures under the skin surface visible to dermatologists. The device records the images, which are sent to a computer that uses an algorithm to compare it with pictures of thousands of malignant and benign lesions to determine the likelihood of skin cancer.
Irvine, Calif.-based MiCardia Corp. received CE Mark approval to begin marketing its next-generation enCorSQ mitral valve repair system in the European Union. The devices, surgically implanted as a treatment for mitral regurgitation, is the only mitral valve repair device can be adjusted without additional surgery. The device can be activated, resulting in a shape change to respond to the progressive nature of mitral regurgitation.
Santa Clara, Calif.-based OptiMedica Corp. won CE Mark approval for its Catalys precision laser system for use in cataract surgery. The company hopes to ship its first system in Europe in the fourth quarter of 2011.