Lineus Medical has been cleared to sell its first medical device, which aims to reduce mechanical complications with IV catheters.
The U.S. Food and Drug Administration has cleared the Fayetteville-based medical company’s SafeBreak Vascular product for sale. The company announced that SafeBreak Vascular was the first Force-Activated Separation Device that would be permitted to be sold in the United States through the FDA’S De Novo review process.
Founded by the company’s chief technology officer Spencer Jones in 2015, Lineus Medical has been dedicated to developing and commercializing SafeBreak Vascular. Achieving FDA De Novo Designation as a Class II device is no doubt the biggest milestone to date for our company. We’re ecstatic about reaching this inflection point and eager to start executing on our product launch plan. It took an incredible amount of perseverance, a lot of investment, and a talented team to overcome the challenges we faced along the way,” Jones said in a statement.
With the SafeBreak Vascular device, IVs will separate when there are large pull forces, and a valve in each end of the SafeBreak will close. The IV on the patient side remains intact and prevents the patient from bleeding, while on the IV pump side, the valve closes to stop the pump.
A new SafeBreak Vascular can be installed without a new catheter or needle sticks and the old device can be discarded. According to the company, the device has been developed to “work with all types of medical tubing,” including feeding tubes, IV lines and urinary catheters.