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FDA clears scoring balloon catheters with larger diameter

July 3, 2015

Spectranetics recently announced that it has received FDA 510(k) clearance for a scoring balloon catheter in diameters of 7 mm and 8 mm to treat a narrowed fistula during hemodialysis in patients with coronary or peripheral artery disease, according to a press release.

The AngioSculpt Percutaneous Transluminal Angioplasty Scoring Balloon Catheter (Spectranetics) is intended to treat a difficult patient population with lesions that are resistant to standard balloon angioplasty. The approved diameter sizes are also appropriate for the preparation of highly calcified lesions in the iliac and superficial femoral arteries, which can be challenging for routine stent placement, according to the release.

In the Journals

Physician urges FDA not to lift restrictions on drug makers’ claims about their products

July 3, 2015
Drug regulations and a governing body to mandate them is a necessity for patients’ safety and health care providers’ peace-of-mind, according to a recently…
Lori C. Jordan, MD, PhD In the Journals

ED rapid response plan helps diagnose pediatric stroke symptoms

July 2, 2015
Among children presenting to the ED of a single center with brain attacks when a pediatric acute stroke protocol was activated, 40% had a stroke or other neurological…
In the Journals

CHD linked to osteoporosis in older adults

July 2, 2015
Older adults with a history of coronary heart disease have a substantially lower cortical volumetric bone mineral density at the distal radius, putting them at risk for…
Xavier PiSunyer In the Journals

Saxenda linked to reduced body weight, improved metabolic control

July 2, 2015
Reduced body weight and improved metabolic control were found with once-daily subcutaneous Saxenda as an add-on to diet and exercise, according to recent study findings…
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This activity is supported by an educational grant from Daiichi Sankyo, Inc. and Lilly USA, LLC

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VIDEO: Knowledge of supplements and drug interactions essential for HF practitioners

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No commercial support for this activity.

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