2014 PAD News & Research
Levant 2 Results Presented at VIVA 2014 -- December 8, 2014
The 12-month results for the LEVANT 2 trial presented at VIVA 2014 showed a 30% improvement in primary patency compared to plain balloon angioplasty for treatment of femoropopliteal lesions. The balloon used is the Bard Lutonix 0358 paclitaxel coated balloon, available at 4-6 mm in diameter and up to 150 mm long. Read More
Medtronic's IN.PACT Admiral Closes in on FDA Approval -- December 8, 2014
Following promising 1-year results from IN.PACT SFA trial, Medtronic hopes to achieve United States Food and Drug Administration approval for its paclitaxel coated balloon for use in treatment of superficial femoral artery diease. Read More
Medtronic Stops IN.PACT DEEP Trial -- December 8, 2014
The IN.PACT DEEP trial conducted by Medtronic was prematurely stopped because early results showed no clinical benefit using the paclitaxel drug coated balloon over plain balloon angioplasty of below the knee lesions in patients with critical limb ischemia. Read More
1 - Year IN.PACT SFA Results Released -- April 13, 2014
331 patients enrolled in the trial were randomized to either the IN.PACT Admiral (Medtronic Inc., Minneapolis, MN) paclitaxel-coated balloon or plain balloon angioplasty. 1-year results showed 82.2% vs. 52.4% (p<0.001) advantage in primary patency for the IN.PACT balloon cohort. Read More
EXCITE ISR Achieves Statistical Endpoint; 501(k) Application on its Way -- February 28, 2014
Spectranetics has achieved statistical significance with respect to their 30-day freedom from major adverse event endpoint for the EXCITE ISR trial, which compared standard balloon angioplasty to angioplasty plus laser atherectomy. The company anticipates submitting the 501(k) application for FDA-approvement of the laser atherectomy device. Read More
Boston Scientific Launches OffRoad Re-entry Catheter System -- February 5, 2014
Due to favorable results of the RE-ROUTE clinical trial, Boston Scientific has decided to launch the unique re-entry catheter, which uses a conical-shaped positioning balloon to help direct a microcatheter to re-enter the vessel lumen. Read More
Review of Atherectomy in the Peripheral Vessels -- January 28, 2014
This review paper amasses data from two randomized trials along with several registry and single-arm studies, and studies atherectomy usage as a stand-alone and in conjuctive therapy in infrainguinal arterial disease.
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