Feature | August 19, 2013

Medtronic Submits Drug-Eluting Balloon for FDA Review

Vendor hopes for pre-market approval for novel peripheral angioplasty device in second half of 2015

August 19, 2013 — Medtronic Inc. announced the submission of its first pre-market approval (PMA) module to the U.S. Food and Drug Administration (FDA) for the IN.PACT Admiral drug-eluting balloon. Designed to treat atherosclerotic lesions in the superficial femoral artery (SFA), the novel angioplasty device remains investigational in the United States.

“Pending FDA approval, we remain on track to launch the IN.PACT Admiral drug-eluting balloon in the United States during the second half of calendar year 2015,” said Tony Semedo, president of Medtronic’s Endovascular Therapies business. “In the meantime, we will continue working with leading healthcare providers and researchers around the world to amass clinical and economic evidence to support the global adoption of this innovative medical technology as an important addition to the treatment options for peripheral artery disease in the lower extremities.”

The ongoing global clinical program of IN.PACT drug-eluting balloons for the treatment of peripheral artery disease (PAD) in the lower extremities includes 24 studies involving more than 4,200 patients at approximately 230 sites worldwide. A combination of physician-initiated and company-sponsored studies, the program will fully characterize the safety and efficacy of these combination devices in a variety of peripheral vascular beds, including below-the-knee arteries.

Medtronic’s PMA application for the IN.PACT Admiral drug-eluting balloon will include clinical data from the IN.PACT SFA I and SFA II pivotal studies, the IN.PACT SFA II pharmacokinetics (PK) study, and the IN.PACT Global study, which have enrolled a total of more than 1,000 patients to date.

IN.PACT drug-eluting balloons feature a proprietary coating called FreePac that is a formulation of the antiproliferative drug paclitaxel and the biocompatible excipient urea, which facilitates rapid absorption of the drug into the vessel wall.

Several IN.PACT drug-eluting balloons received CE mark in 2008 and 2009 and are available in many countries around the world. In the United States, the IN.PACT Admiral drug-eluting balloon is limited to investigational use, and, like all drug-eluting balloons, is not yet commercially available.

The treatment of PAD varies by stage of progression and other factors, with lifestyle modifications aimed at risk factor reduction recommended for all stages. Drug-eluting balloons represent a relatively recent addition to the procedural approaches, which also include atherectomy, balloon angioplasty and stenting. In cases involving especially long lesions, bypass surgery can create a new route for blood flow around the diseased artery.

For more information: www.medtronic.com

Related Content

Medtronic, In.Pact Admiral drug-coated balloon, trial data, VIVA
News | Drug-Eluting Balloons| September 22, 2016
New data presented at the Vascular Interventional Advances (VIVA) conference demonstrated the durability, consistency...
Medtronic, IN.PACT Admiral drug-coated balloon, DCB, FDA approval, in-stent restenosis, ISR
Technology | Drug-Eluting Balloons| September 19, 2016
Medtronic plc announced that the U.S. Food and Drug Administration (FDA) approved the IN.PACT Admiral drug-coated...
VIVA 2016, late breaking trials, cath lab
Feature | Cath Lab| September 14, 2016
Vascular Interventional Advances (VIVA) 2016 released its list late-breaking research presentations in vascular inter
Medtronic, In.Pact Admiral drug coated balloon, DCB, FDA approval, 150 mm length
Technology | Drug-Eluting Balloons| July 18, 2016
Medtronic plc has received U.S. Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon...
News | Drug-Eluting Balloons| June 03, 2016
June 3, 2016 — Cardionovum GmbH recently announced the completion of enrollment of the RAPID trial.
Intact Vascular, Tack Endovascular System

The Intact Vascular Tack Endovascular System is designed to spot stent dissections with a short, self-expanding 6 mm long stent that can expand to vessel diameters between 2.5-6 mm, so exact sizing is not needed.

Feature | Peripheral Arterial Disease (PAD)| February 22, 2016 | Dave Fornell
It is estimated that more than 10 million people in the United States are affected by...
Medtronic, CE Mark, IN.PACT Admiral DEB, arteriovenous AV access, hemodialysis, end-stage renal disease patients
News | Drug-Eluting Balloons| January 18, 2016
Medtronic plc announced that the IN.PACT Admiral drug eluting balloon (DEB) has received CE (Conformité Européene) Mark...
ISAR-DESIRE 4 trial, TCT 2015, drug-coated balloon, DCB, scoring balloon, SCB, drug-eluting stent restenosis

Image courtesy of Medtronic

Feature | Drug-Eluting Balloons| October 22, 2015
Results from the ISAR-DESIRE 4 trial indicate that use of a scoring balloon plus a paclitaxel-coated balloon (PCB) was...
IN.PACT SFA study, TCT 2015, drug-coated balloons, PTA, SFA disease, superficial femoral artery

Image courtesy of Medtronic

Feature | Peripheral Arterial Disease (PAD)| October 18, 2015
Two-year results from the IN.PACT SFA study found the use of a drug-coated balloon was superior to conventional...
Lutonix Global Real-World Registry results, TCT 2015, Lutonix 035 DCB, peripheral arterial disease, PAD

Image courtesy of C.R. Bard

News | Drug-Eluting Balloons| October 15, 2015
C. R. Bard Inc. announced the presentation of the 12-month results from the Lutonix Global Real-World Registry at the...
Overlay Init