Medtronic Receives CE Mark for 200mm and 250mm IN.PACT Admiral Drug-Coated Balloons

September 7, 2021: Medtronic launches the 200 mm and 250mm IN.PACT™  Admiral™ drug-coated balloon (DCB) in Europe after receiving CE (Conformité Européene) Mark. The product is intended to treat long complex femoropopliteal lesions efficiently in patients with peripheral artery disease (PAD). The 200mm and 250mm IN.PACT Admiral DCB enables physicians to treat longer lesions using a single DCB instead of multiple DCBs.

Professor Thomas Zeller, M.D., director of the Department of Angiology at Universitaets-Herzzentrum, Freiburg-Bad Krozingen, Germany, performed the first case using the new sizes of the IN.PACT Admiral DCB in Europe. He stated, “Patients with SFA disease often present with longer and more complex lesions as time goes on, which makes it challenging to effectively treat the entire segment. We know the IN.PACT Admiral DCB is effective in providing durable results, and now with the longer sizes, it is a more efficient treatment option for these difficult to treat lesions. Using the new sizes of the IN.PACT Admiral DCB could potentially lead to saving both time and money by using one balloon instead of multiple balloons.”

About the IN.PACT Admiral DCB

The IN.PACT Admiral DCB is a clinically established, primary endovascular therapy, which has been shown to provided durable, consistent and safe outcomes across multiple clinical trials, as well as across complex patient and lesion types. With more than 3,500 patients enrolled in 21 clinical studies and 600,000+ patients treated worldwide, the IN.PACT Admiral DCB  is the preferred DCB for treatment of femoropopliteal disease  allowing reduced interventions and preserving future treatment options. A DCBs’ primary mode of action is physical dilatation of the vessel lumen by PTA, followed by the delivery of paclitaxel. The unique formulation of IN.PACT Admiral DCB with its drug dose, excipient, and crystallinity, provides sustained drug residence in the tissue, leading to an effective and durable outcome.  

The IN.PACT Admiral DCB received CE mark in March 2009 to treat PAD and was approved by the FDA in December 2014 to treat superficial femoral and popliteal arteries. 

The 200 mm and 250 mm IN.PACT Admiral DCB received FDA approval in May of 2018. It was the first DCB to receive approval by the U.S. FDA for the treatment of in-stent restenosis and lesions up to 360mm in length.  

“The European launch of the longer IN.PACT Admiral DCBs not only reaffirms Medtronic’s commitment to innovation in the DCB space, but also to the clinical community we serve” said Dave Moeller, president of the Peripheral Vascular Health business, which is part of the Cardiovascular Portfolio at Medtronic. “Offering clinicians more options to help treat these complex lesions remains a top priority for Medtronic.”