FDA Again Warns on Balloon Angioplasty for Neurologic Disorders

(MedPage Today) -- Says transvascular autonomic modulation is off-label and dangerous
Source: MedPage Today Primary Care - Category: Primary Care Source Type: news

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A 62-year-old woman with persistent chronic thromboembolic pulmonary hypertension (CTEPH) status after pulmonary thromboendarterectomy presented with worsening exercise capacity and continued dyspnea requiring 3 L O2 at home.  Ventilation perfusion scan (Fig 1) demonstrated A high probability of pulmonary embolism. Pulmonary angiography (Fig 2) revealed multifocal subsegmental arterial occlusions and stenoses consistent with CTEPH. Her medications included macitentan, riociguat, and selexipag for CTEPH.
Source: Journal of Vascular and Interventional Radiology : JVIR - Category: Radiology Authors: Tags: Images in IR Source Type: research
Cook Medical recalled certain lots of a balloon catheter used for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries after receiving multiple complaints of balloons bursting below the rated burst pressure. The company has determined that the problem affects the Advance Enforcer 35 Focal Force PTA Balloon Catheters manufactured with specific balloon material lots manufactured between October 3, 2018, and December 17, 2018. The recall affects about 33 devices that were distributed to the U.S. market between October 29, 2018, to March 21, 2019, FDA said.Â&nb...
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news
Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm, 5FR/135cm, Catalog Number ASB5-35-135-6-4, REF Number G35252 Product Usage: The Advance Enforcer 35 Focal-Force PTA Balloon Catheter is intended for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral, as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Not for use in the cerebral or coronary vasculature.
Source: Medical Device Recalls - Category: Medical Devices Source Type: alerts
AbstractLesion characteristics determined by angiography after balloon angioplasty such as residual dimeter stenosis (DS) or dissection type has been used to determine the treatment method of drug-coated balloon (DCB) or metal stent for de novo coronary lesions. The aim of this study is to identify angiographic and functional mismatch using residual DS, dissection type and fractional flow reserve (FFR). Baseline and post-balloon parameters were obtained from 151 patients with 167 lesions. Angiographically significant parameters after balloon angioplasty are residual DS  >  30% or dissection type C or more....
Source: The International Journal of Cardiovascular Imaging - Category: Radiology Source Type: research
This study aimed to determine the efficacy and mechanism of the DCBA using imaging studies both immediately after the DCBA and during the follow-up period. We enrolled 15 consecutive patients who underwent DCBA for in-stent restenosis (ISR). The in-stent neointimal volume was evaluated using optical coherence tomography (OCT), and the in-stent yellow grade was assessed using coronary angioscopy (CAS) immediately after DCBA and during the median follow-up period of 9 (8 –15) months. The neointimal volume was significantly reduced from 77.1 ± 36.2 mm3 at baseline to 60.2  ±&...
Source: Heart and Vessels - Category: Cardiology Source Type: research
CONCLUSION: Despite the invasiveness, direct atrial outflow procedures remain a valid alternative in carefully selected patients with adequate cardiopulmonary reserve. PMID: 31188045 [PubMed - as supplied by publisher]
Source: The Journal of Vascular Access - Category: Surgery Tags: J Vasc Access Source Type: research
Orchestra BioMed gained a powerful strategic partner to help push one of its lead products to the market. Tokyo-based Terumo has agreed to give New Hope, PA-based Orchestra a $30 million up-front payment and an equity commitment of $5 million. Terumo said it will also make “substantial” future clinical and regulatory milestone payments to Orchestra BioMed, plus a “strong commitment” to finance and execute a global clinical program in collaboration with Orchestra to gain regulatory approval for the Virtue sirolimus-eluting balloon (SEB). Orchestra said ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
In the original publication of the article Fig. 1 was published incorrectly. The corrected Fig. 1 is given in this correction.
Source: The International Journal of Cardiovascular Imaging - Category: Radiology Source Type: research
First and only non-coated drug-eluting angioplasty balloon that delivers a proprietary bioabsorbable, sustained-release formulation of sirolimus TOKYO, June 13, 2019 -- (Healthcare Sales &Marketing Network) -- Terumo Corporation (TSE: 4543), a leading... Devices, Interventional, Licensing Terumo, Orchestra BioMed, Virtue SEB, Sirolimus, drug eluting balloon
Source: HSMN NewsFeed - Category: Pharmaceuticals Source Type: news
Vein graft stenosis is a critical complication of lower-limb bypass surgery. For vein graft stenosis, balloon angioplasty has been performed instead of surgical revision in recent years. We therefore investigated the effectiveness of the balloon angioplasty for vein graft stenosis.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research, Basic Science Source Type: research
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