CardioExchange Archive

January 5th, 2015

FDA Approves New Drug-Coated Balloon to Open Blocked Leg Arteries

Larry Husten, PHD

Medtronic said today that it had received approval from the FDA to market its IN.PACT Admiral drug-coated balloon (DCB) to treat peripheral artery disease (PAD) in the superficial femoral and popliteal arteries. The device is the second DCB to gain FDA approval. Last October the FDA approved CR Bard’s Lutonix DCB for a similar indication. The new DCB uses the anti-proliferative drug paclitaxel, […]

---

June 13th, 2014

FDA Advisory Panel Supports Novel Drug-Coated Balloon

Larry Husten, PHD

The FDA’s Circulatory System Devices advisory panel voted unanimously on Thursday to support approval of CR Bard’s Lutonix Drug-Coated Balloon (DCB). It would be used to enlarge arteries in a subset of patients who have peripheral arterial disease — including obstructive de novo or nonstented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries […]

---

November 15th, 2012

FDA Approves Zilver PTX Drug-Eluting Stent for Peripheral Arterial Disease

Larry Husten, PHD

The FDA today approved Cook Medical’s Zilver PTX stent. It is the first drug-eluting stent (DES) approved for the treatment of peripheral arterial disease (PAD) in the superficial femoral and proximal (i.e., above the knee) popliteal artery. The new stent will provide a new treatment option for patients with PAD. Current treatments include exercise, drug […]

---

October 14th, 2011

FDA Advisory Panel Recommends First DES For PAD

Larry Husten, PHD

The FDA Circulatory System Devices Panel voted 11-0 on Thursday to support the premarket approval application for the Zilver PTX drug-eluting stent, manufactured by Cook Medical. The self-expanding, paclitaxel-coated stent would be the first DES approved for use in peripheral arterial disease of the above-the-knee femoropopliteal arteries. Cook Medical press release

---