SpineGuard wins FDA nod for PediGuard threaded DSG device.

SpineGuard  (EPA:ALSGD) said today it won FDA 510(k) clearance for its PediGuard threaded Dynamic Surgical Guidance device designed for pedicle screw insertion.

The PediGuard device is available in various designs, the company said, to accommodate both surgeon’s preferences and patient anatomies.

“We are very excited by the clearance of our PediGuard Threaded device, which brings a new generation of DSG-enabled probes to the US market, offering spine surgeons the added clinical benefit of reducing surgical steps in fusion surgery. This clearance allows our network of agents to initiate the commercial phase of this unique value proposition in a $7-billion market that is under price pressure and in tremendous need for differentiation,” CTO Stéphane Bette said in a press release.

In procedures, the device’s single-use DSG pin embedded with a bipolar sensor is inserted into the cannula of the threaded shaft and connected to the electronic processor inside the DSG handle, the company said. The distal tip of the shaft includes and awl-like tip to allow for redirection of the device until the tip is past the pedicle isthmus.

“We have received very positive feedback on our new DSG device from our spine surgeon customers in Europe and Asia since its introduction earlier this year. We were eager to extend its benefits to surgeons, patients and hospitals in the US. In line with healthcare systems’ expectations of better clinical outcomes and surgical efficiency, SpineGuard continues to bring real-time digital technology to the operating room,” CEO Pierre Jérôme said in a prepared statement.

In January, SpineGuard said it landed a debt financing round worth some $8.4 million (€7.7 million) for its disposable spine surgery devices.

Paris- and San Francisco-based SpineGuard said the round included a $1.6 million (€1.5 million) “innovation loan” from Bpifrance and $6.8 million (€6.2 million) in a 4-tranche bond offering with IPF Partners. SpineGuard said it drew down the 1st $3.3 million (€ 3 million) Dec. 28.

The post SpineGuard wins FDA nod for PediGuard threaded DSG device. appeared first on MassDevice.

from MassDevice http://ift.tt/21oPyA2