A Medical Device Daily
NeuroVasx (Maple Grove, Minnesota), a developer of technologies for the treatment of hemorrhagic and ischemic stroke, said it has received the CE mark for its cPAX Aneurysm Treatment System.
The cPAX System is a minimally invasive device for the embolization of cerebral aneurysms, abnormal bulges or sacs in the wall of an artery in the brain.
cPAX is a polymer strand delivered through a microcatheter using the same delivery technique as the currently-used platinum coil technology. It was designed to achieve more complete filling of the aneurysm using fewer devices and providing the physician with the ability to detach the device at any point vs. a fixed detachment zone common to platinum coils.
NeuroVasx said the polymeric material also allows for non-invasive CT and MRI scans free of metallic artifact for what it characterized as "a more accurate patient follow-up assessment."
President/CEO Eric Timko said, "This initial clearance represents a significant milestone for NeuroVasx and our efforts to become a leader in the treatment of cerebral aneurysms. We believe that cPAX offers substantial advantages over traditional platinum coils."
He added, "cPAX reduces the amount of devices per procedure, simplifying the delivery and shortening procedure times. Its soft, pliable material allows for packing densities of up to 60%, a particularly important advantage when treating larger or wide necked aneurysms."
Timko said the company is anticipating a pending 510(k) clearance of cPAX by the FDA, which will be followed by initial U.S. commercialization efforts.
A cerebral aneurysm is an abnormal bulge or sac in the wall of an artery in the brain which can be caused by a number of factors including congenital defects, high blood pressure, atherosclerosis, cancer, drug use or head trauma. NeuroVasx said that if a cerebral aneurysm ruptures, it can lead to a hemorrhagic stroke, or bleeding on the brain.
It cited National Institutes of Health (Bethesda, Maryland) statistics showing that about 40% of such patients do not survive the first 24 hours. The worldwide incidence of cerebral aneurysms is estimated to be 320,000 annually, roughly 200,000 of which may be treatable with intracranial surgery or minimally invasive techniques, according to the company.
NeuroVasx said the worldwide market potential for stroke treatment devices is estimated to be in excess of $3 billion.
New IV robot shown at EAHP
Health Robotics (Bozen, Italy) has reported the European launch of its i.v.STATION Robot with a demonstration at this week's European Association of Hospital Pharmacists (EAHP) meeting in Barcelona, Spain.
Health Robotics also noted the showcasing of CytoCare, which it termed "the world's only Chemotherapy IV Robot," at the EAHP booth of one of its strategic partners, B Braun (Melsungen, Germany).
The company said rhe primary challenges in today's IV admixture operations are serious medication errors, high costs, turnaround time, lack of sterility, wasted materials, lack of audit trails, motion injuries, space constraints and difficulty in maintaining adequate and trained staff.
It said i.v.STATION was designed to address these issues, representing a "revolutionary approach in the quest for safe, accurate, efficient, cost effective, and ready-to-administer IV admixtures."
i.v.STATION offers what Health Robotics calls "unprecedented final container flexibility, life-critical patient safety, and robotic precision and performance."
Health Robotics has reached agreements for 16 i.v.STATION installations in 2009 at locations in Italy, Japan, Saudi Arabia, Turkey, United Arab Emirates, the UK and U.S.
i.v.STATION may be deployed in a variety of locations, including central and satellite pharmacies and direct patient care areas, due to its self-contained form and small foot print.
Finnish firm gathers funds
Nexstim Oy (Helsinki, Finland), a medical device company developing non-invasive brain imaging technologies, said it has secured about €6 million from existing shareholders and TEKES, the Finnish Funding Agency for Technology and Innovation.
To date, Nexstim has raised €20 million, of which roughly €14 million came in the past two years.
Nexstim's existing investors have agreed to subscribe to a €3 million loan-based convertible bond. Investors include HealthCap and Life Sciences Partners, as well as Sitra and Finnish Industry Investment Ltd. The company also received grants and loans of €2.72 million from TEKES to fund a research and clinical development program in stroke.
Managing Director Jukka-Pekka Särkkä said, "The new financing enables us to finalize our application to the U.S. FDA for marketing clearance of the NBS System. The TEKES funding will help significantly accelerate our program for NBS in stroke."
Nexstim was founded in 2000 to commercialize Navigated Brain Stimulation (NBS), the combination of stereotactic MRI-guided transcranial magnetic stimulation and EEG/EMG response measurement. With NBS, an operator moves a hand-held TMS coil over a patient s head to deliver a series of short pulses to briefly activate the upper layer of the brain. Responses in the patient's muscles, measured by EMG, reveal the critical motor areas in the cortex.
NBS has multiple applications in functional brain diagnostics, including cortical mapping prior to surgery and evaluating brain damage following stroke.
Ziehm Solo was launched at ECR
Ziehm Imaging (Nuremberg, Germany) launched its new, compact Ziehm Solo C-arm at the recent European Congress of Radiology (ECR) in Vienna, Austria. The company said Ziehm Solo was designed to meet the needs of pain management and orthopedic imaging, as well as trauma and spine surgery.
"By virtue of its attractive price point, it is an interesting option for more limited hospital budgets," the company said. It added that it responded to the increasing demands on the limited space in an OR's sterile field by designing a system that occupies minimal space while providing optimal image processing and display.
"The CCD Camera can produce more than 4,000 gray scales," Ziehm said. "The optionally integrated metal correction program limits the overexposure of a fluoroscopic image often caused by metal implants by recognizing metal objects such as screws, plates, implants and instrumentation in the field of view and adapting generator output accordingly."