Carticept Medical (Alpharetta, Georgia) is increasing the accuracy of its Navigator Delivery System, a drug delivery application, with the addition of an ultrasound component. The med-tech startup said that it had received FDA clearance to market the device with the addition of ultrasound guidance.
The company says that the newly integrated application will help to increase the efficiency, accuracy and safety of administering pain-relieving medications for joint pain.
“It's been a fairly lengthy development cycle and it's required a couple of rounds of investment from our venture capital partners but we're delighted we're now on the cusp of commercializing the product,“ said Tim Patrick, CEO of Carticept.
Patrick noted that the company has raised $43 million since its inception.
The device is a computer-controlled, drug delivery system designed to automate preparation and delivery of pain relieving medications for joint pain. The system prepares physician-prescribed injections from standard multi-dose anesthetic and steroid drug vials.
In addition to eliminating multiple needle exposures to healthcare workers and minimizing the potential for contamination of the medication, automating this procedure ensures accurate dose preparation and saves significant labor for a busy physician practice. The injection is then delivered into the painful joint under precise computer control. The Navigator DS automates accurate medical record keeping by recording the treatment data for transfer to an electronic record management system or direct print-out.
“In the previous iteration we had a system that would help us hold the data, the standard vial, and prepare those doses at the request of the physician by moving a foot pedal,“ Patrick told Biomedical Business & Technology. “The use of ultrasound with the device is really a great benefit as it relates to the efficiency and accuracy of filling that dose. Ultrasound has been used to accurately locate the tip of the needle in the tissue and there have been a lot of studies that have been done that show when you have ultrasound guidance vs. no guidance that clinicians are able to do a significantly better job of guiding that needle where it needs to be.“
He added that “for the first time ever we've got these two systems that are sharing information together.“
“When a physician is performing an ultrasound injection with the integrated system, they're looking at an image of the drug syringe on top of the ultrasound screen. It shows how much drug remains to be delivered,“ he said. “It shows them the inline pressure and it also tells them the drugs that are being delivered and captures that information automatically. So all of the demographic info that would have been available for them on the ultrasound and all of the information that would be available to them on the Navigator is now available to them automatically sequenced together and stored for them.“
The ultrasound component of the device was manufactured by Sonosite (Bothell, Washington), an equity investor in the company, and has already been cleared by the FDA. The company had to get an additional clearance for the combination of both devices.
Carticept has CE mark approval for two generations of the device, with the latest including an ultrasound component. The device hasn't yet been launched in Europe, but has been introduced to a number of sites in the UK, the company notes.
The firm plans to launch the device in early 2012.
The company which was founded in 2005, according to its website, also has started a multi-center study of its Cartiva Synthetic Cartilage Implant (SCI). The study aims to determine the effectiveness of Cartiva SCI in comparison to arthrodesis (joint fusion), the current standard of care, for reducing the debilitating pain associated with osteoarthritis of the first metatarsophalangeal joint.
Cartiva SCI is a polyvinyl alcohol cryogel device designed to mimic natural cartilage. The device is intended to maintain natural joint mechanics by repairing focal cartilage defects while minimizing the resection of healthy tissue. Due to its similar properties to native cartilage, joint resurfacing with Cartiva SCI does not require replacement of the opposing surface. It is expected that patients may be able to return to normal activities more quickly than when treated with joint fusion.
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