Medtech in a Minute: Integra's FDA Warning Letter, and More

FDA Hits Integra with a Warning Letter

An two-month FDA inspection of Integra LifeSciences' Boston, MA manufacturing facility has resulted in a warning letter. This comes as no surprise given the company's earlier announcement that it has halted production and initiated a global recall of all products made at that facility. A company spokesperson told MD+DI the company will not resume production at the Boston, MA facility until it has addressed FDA's concerns and are "confident the facility meets the strictest regulatory and product quality standards." This is anticipated to be complete by the end of the calendar year, the spokesperson said.

Medtronic Recalls Dialysis Catheters

Medtronic has issued a recall on certain Mahurkar triple lumen hemodialysis catheters due to occlusion in the tip of the catheter's center lumen. Medtronic said it discovered the problem during routine manufacturing related testing and the company has reported no confirmed complaints, adverse events, or deaths related to the issue. The company said the occlusion was caused by excessive MDX, a silicone-based lubricant used to coat the catheter tip.

Microbot Inks Manufacturing Deal with Medimor

Microbot Medical recently announced it has signed a manufacturing agreement with Medimor to advance the commercialization of its Liberty Robotic Surgical System. Liberty is a single use endovascular surgical robotic system designed to streamline endovascular procedures.

And in case you missed our last Medtech in a Minute report...

Pivot! Abbott Discontinues Trifecta Valve

In a move that comes about 5 months after FDA raised durability concerns about Abbott's Trifecta heart valves, the company has permanently withdrawn the devices from the market. FDA alerted healthcare providers in late February about the potential risk of early structural valve deterioration (SVD) with Abbott Trifecta valves, including the Trifecta with Glide Technology (Trifecta GT), which feature leaflets externally mounted to the valve frame. According to the agency, published literature suggests a higher cumulative incidence of early (five years or less) SVD for Trifecta valves compared to competing surgical aortic valves.

Not So Sweet Home Alabama 

Baxter will reportedly cease production at its plant in Opelika, AL, affecting nearly 500 employees. Baxter leadership said the closure is not a reflection on the quality of the workforce or the business climate in Opelika, “but was brought on by global market conditions that have impacted demand and overseas competition.”