FDA Approves IN.PACT Admiral DCB for Expanded Indication

News

Submitted on Fri, 05/11/2018 - 11:43
FDA

The FDA has approved the IN.PACT Admiral drug-coated balloon (DCB) to treat long superficial femoral artery (SFA) lesions up to 360 mm in patients with peripheral artery disease, according to Medtronic.

 

The approval was issued as a result of data from the complex lesion imaging cohorts of the IN.PACT Global study, which included long lesion, in-stent restenosis, and chronic total occlusion groups with lesion lengths >180mm. Data from a total of 227 patients with mean lesion lengths of 28.7 ± 7.1 cm were analyzed, and results indicated a patency rate of 89.1% at day 360. Additionally, there was a clinically-driven target revascularization rate of 7.1%.

 

"Data from the IN.PACT Global Study demonstrate that IN.PACT Admiral DCB is a safe and effective treatment option in real-world patients with lesions beyond 180 mm, frequently comprised of in-stent restenosis and chronic total occlusions," Daniel Clair, MD, said in a press release from Medtronic. Dr. Clair is chair of the Department of Surgery for University of South Carolina (USC) and the Palmetto Health-USC Medical Group. He added, "More specifically, these results show maintenance of strong clinical outcomes, including a high primary patency rate and limited need for reintervention in patients exhibiting these complex, long lesions - among the most prevalent cases we see. The FDA's approval of this expanded indication now offers U.S. physicians a clinically-proven endovascular therapy to address this critical patient need."

 

According to an overview issued by FDA, the device should not be used in the following situations:

  • Patients with narrowed arteries in the heart, kidneys, or brain.
  • Patients who cannot take recommended medicines that thin the blood and prevent blood clots.
  • Patients with a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the delivery system.
  • Patients with a known hypersensitivity to paclitaxel or drugs with similar characteristics as paclitaxel.
  • Women who are breastfeeding, pregnant, or intend to become pregnant; or men intending to father children.

 

References

1. Medtronic IN.PACT™ Admiral™ Paclitaxel-Coated PTA Balloon Catheter - P140010/S037. https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm606219.htm. Published May 1, 2018. Accessed May 11, 2018.

2. Medtronic IN.PACT(TM) Admiral(TM) Drug Coated Balloon Receives FDA Approval to Treat Long SFA Lesions [press release]. 23 April 2018. Globenewswire.