Technology | Drug-Eluting Balloons | May 03, 2018

Drug-coated In.Pact Admiral Balloon Cleared for Longer Lesions

The Medtronic In.Pact Admiral Paclitaxel-coated (DCB) Percutaneous Transluminal Angioplasty Balloon Catheter is now indicated for lesions up to 360 mm in length.

May 3, 2018 — The U.S. Food and Drug Administration (FDA) has expanded the indication for the Medtronic In.Pact Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter to include lesions up to 360 mm in length. 

This device is indicated for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo, restenotic, or in-stent restenotic lesions with lengths up to 360 mm in superficial femoral or popliteal arteries with reference vessel diameters of 4-7 mm.

The drug-coated balloon (DCB) helps re-open blocked or narrowed arteries in the thigh and knee due to peripheral artery disease (PAD). This device can be used to prevent re-narrowing within a stent placed previously to open the blood vessel or to treat long blockages. The balloon is coated on its outer surface with the drug paclitaxel, which is an anti-proliferative drug that prevents restenosis.

"Across SFA trials, In.Pact Admiral has consistently demonstrated superior safety and efficacy compared to PTA," said Osamu Iida, M.D., Kansai Rosai Hospital, Japan, during presnetation of data on the IN.PACT Admiral SFA Japan trial in February. "We are pleased to see comparable results in Japan at two years with durable patency outcomes, low TLR and no instances of thrombosis. There has been a critical unmet need in Japan for new technologies that safely and effectively treat PAD, and we believe In.Pact Admiral is well-positioned to meet this need."

IN.PACT Admiral SFA Japan demonstrated 79.8 percent primary patency in the DCB group as compared to 46.9 percent in the PTA group at two years based on Kaplan-Meier Estimate (p<0.001). The two-year results also demonstrated a CD-TLR rate of 9.1 percent for the DCB group compared to 20.7 percent in the PTA group (p=0.177) and a freedom from CD-TLR based on Kaplan-Meier Estimate of 90.8 for the DCB group compared to 81.3 percent in the PTA group (p=0.114). In IN.PACT SFA Japan, major adverse events were also lower for the DCB at two years (15.2 percent compared to 24.1 percent in the PTA group; p=0.384), with no major target limb amputations. There were no additional safety concerns at two years.

Read the recent article "In.Pact Admiral Balloon Demonstrates Consistent, Durable Outcomes in LINC 2018 Studies."

Here is the link to the FDA approval letter.

For more information: www.medtronic.com


Related Content

News | Balloon Catheter

January 18, 2024 — Summa Therapeutics, LLC announced that the first-in-man injectable angioplasty procedures for ...

Home January 18, 2024
Home
News | Balloon Catheter
Cardiovascular Systems, Inc., a medical device company developing and commercializing innovative interventional ...
Home February 25, 2022
Home
News | Balloon Catheter

February 15, 2022 – CERENOVUS, an emerging leader in neurovascular care and part of Johnson & Johnson Medical Devices ...

Home February 15, 2022
Home
News | Balloon Catheter

May 20, 2021 — Boston Scientific Corporation announced it has initiated the AGENT IDE trial for the Agent Drug-Coated ...

Home May 20, 2021
Home
Feature | Balloon Catheter | By Dave Fornell, Editor

The first devices developed for interventional cardiology were percutaneous transluminal coronary angioplasty (PTCA) ...

Home March 16, 2021
Home
Feature | Balloon Catheter

February 17, 2021 — The U.S. Food and Drug Administration (FDA) has cleared Shockwave Medical's Intravascular ...

Home February 17, 2021
Home
News | Balloon Catheter

June 4, 2020 — Transit Scientific announced the U.S. Food and Drug Administration (FDA) cleared the XO Score ...

Home June 04, 2020
Home
News | Balloon Catheter

February 24, 2020 — Abbott has voluntarily recalled specific lots of two types of its coronary angioplasty catheters — ...

Home February 24, 2020
Home
News | Balloon Catheter

July 15, 2019 — Edwards LifeSciences is recalling the IntraClude Intra-Aortic Occlusion Device due to a risk of balloon ...

Home July 15, 2019
Home
Technology | Balloon Catheter

August 23, 2018 — W. L. Gore & Associates Inc. (Gore) announced U.S. Food and Drug Administration (FDA) 510(k) clearance ...

Home August 23, 2018
Home
Subscribe Now