Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter

Company received FDA 510(k) clearance Continued progress in R&D whole-product solutions pipeline EDEN PRAIRIE, Minn. -- (Healthcare Sales &Marketing Network) -- Surmodics, Inc., a leading provider of medical device and in vitro diagnostic technologi... Devices, Interventional, FDA Surmodics, percutaneous transluminal angioplasty, balloon catheter
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news

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ConclusionThe Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group.
Source: CardioVascular and Interventional Radiology - Category: Radiology Source Type: research
CONCLUSIONS: Results from the study showed superior treatment effect with Orchid DCB versus PTA for the treatment of FP ISR, and without an apparent difference in safety. PMID: 31566320 [PubMed - as supplied by publisher]
Source: International Angiology - Category: Cardiology Tags: Int Angiol Source Type: research
Abstract BACKGROUND: A recent summary-level meta-analysis comprising randomized, controlled trials (RCTs) of femoropopliteal paclitaxel-coated balloon and stent intervention identified excess late mortality in the paclitaxel-treated patients. METHODS: We evaluated the safety of the Stellarex drug-coated balloon (DCB) for femoropopliteal artery disease with an independently performed meta-analysis of patient-level data from all patients in the Stellarex femoropopliteal clinical program. To compare mortality after DCB or uncoated percutaneous transluminal angioplasty (PTA), we aggregated data from 2 RCTs compri...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Tags: Clinical research study Source Type: research
CONCLUSION: Our technique of retrieval may be suitable for cases of balloon rupture with a circumferential tear during percutaneous transluminal angioplasty. The technique enables less invasive retrieval and continuation of the percutaneous transluminal angioplasty thereafter. PMID: 31434523 [PubMed - as supplied by publisher]
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Percutaneous transluminal angioplasty (PTA) of the infrainguinal arteries was the first endovascular technique for improving lower extremity circulation. The procedure involves the inflation of a balloon-tipped catheter in stenotic or occluded vessels to improve perfusion and to increase downstream blood flow. New techniques are frequently compared with the results of PTA, making valid and robust PTA data essential. Our objective was to identify papers that present PTA outcomes and to perform a systematic review.
Source: Journal of Vascular Surgery - Category: Surgery Authors: Tags: Abstract from the 2019 Midwestern Vascular Surgical Society Annual Meeting Source Type: research
CONCLUSION: The Freeway Stent Study shows that the usage of DEB as a restenosis prophylaxis seems to be safe and feasible. The 12-month follow-up results give a clear sign in favor of the DEB group. PMID: 31432220 [PubMed - as supplied by publisher]
Source: Nuklearmedizin - Category: Radiology Authors: Tags: Cardiovasc Intervent Radiol Source Type: research
A company backed by serial Tampa Bay entrepreneur Dr.  Kiran Patel has secured a key designation that will help advance a product from the medical device company. Concept Medical Inc. has been granted "Breakthrough Device Designation" from the U.S. Food and Drug Administration for MagicTouch Percutaneous Transluminal Angioplasty, which is a Sirolimu s drug coated balloon catheter, for the treatment of peripheral artery disease. The device is for a disease that takes place below the knee, also…
Source: Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Source Type: news
Authors: Mustapha JA, Brodmann M, Geraghty PJ, Saab F, Settlage RA, Jaff MR, Lutonix BTK Study Investigators Abstract OBJECTIVES: We hypothesized that a drug-coated balloon (DCB) could improve treatment efficacy while maintaining safety when compared with percutaneous transluminal angioplasty (PTA) for the treatment of atherosclerotic infrapopliteal arterial lesions. METHODS: A total of 442 patients with angiographically significant lesions were randomized (2:1) to DCB or PTA. The primary safety and efficacy endpoints were freedom from major adverse limb events and perioperative death (MALE-POD) at 30 days, an...
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
Abstract Percutaneous transluminal angioplasty (PTA) is a routine procedure for the treatment of peripheral arterial disease. However, its main limitation is late restenosis occurring at a 1-year rate of 6%-60%. Restenosis arises from injury to the arterial wall including overstretching, compression and rupture of the atherosclerotic plaque during balloon inflation. It is hypothesized that better long-term angioplasty results are observed if atherosclerotic plaques are removed rather than compressed and fractured. Laser angioplasty is one method to remove atherosclerotic plaques. We discuss the principles of laser...
Source: Diagnostic and Interventional Radiology : The Turkish Society of Radiology - Category: Radiology Authors: Tags: Diagn Interv Radiol Source Type: research
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