5-Year Data for IN.PACT Drug-Coated Balloon in SFA Show Improved Outcomes Over Standard PTA

At last week's Vascular Interventional Advances (VIVA) Annual Meeting in Las Vegas, Medtronic presented five-year final outcomes from its IN.PACT SFA Trial. Of note: Medtronic is the first company to present long-term five-year outcomes for a commercially-available drug-coated balloon (DCB). The data not only reinforced the safety, durability, and efficacy of the IN.PACT Admiral DCB, as seen in previous studies, but also reaffirmed its use as a frontline therapy for the treatment of peripheral artery disease (PAD).
Source: News from Angioplasty.Org - Category: Cardiology Source Type: news

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Authors: Spiliopoulos S, Karamitros A, Reppas L, Brountzos E Abstract Introduction: Percutaneous transluminal angioplasty (PTA) currently remains the endovascular treatment of choice in a large percentage of patients suffering from peripheral artery disease (PAD). However, the mechanism of angioplasty itself can cause some extent of arterial dissection leading to early vessel restenosis/reocclusion. Current endovascular imaging studies have reported a higher rate of arterial dissection than previously reported in literature and advocated the correlation of dissection with poor patency. Thus, there is the need of de...
Source: Expert Review of Medical Devices - Category: Medical Devices Tags: Expert Rev Med Devices Source Type: research
The FDA last week granted pre-market approval to the Tack endovascular repair device developed by Intact Vascular. The Wayne, Pa.-based company’s Tack system is designed to repair dissection complications during balloon angioplasty for peripheral artery disease. Intact said the federal safety watchdog based the April 11 PMA decision on the results of a pivotal, 213-patient single-arm trial that met both its safety and efficacy endpoints. The Tack device won CE Mark approval in the European Union in January 2017. The Toba II study‘s rate of freedom from clinically-driven target lesion revascularization, amputati...
Source: Mass Device - Category: Medical Devices Authors: Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Wall Street Beat Intact Vascular peripheral Source Type: news
The most common clinical presentation of peripheral artery disease (PAD) comprises intermittent claudication though about one third of patients will progress to below-the-knee critical limb ischemia. Currently, percutaneous transluminal angioplasty (PTA) is the standard endovascular therapy employed in this patient population. The Lutonix BTK  IDE multicenter randomized study was conducted to assess the safety and efficacy of the Lutonix DCB for the treatment of stenosis or occlusion of native below-the-knee arteries.
Source: Journal of Vascular and Interventional Radiology : JVIR - Category: Radiology Authors: Tags: Scientific Session 2: Finish the Race Source Type: research
Intimal hyperplasia (IH) is the most common indicator for secondary intervention in peripheral vascular disease. Matrix metalloproteinases (MMPs) play a role in IH development due to their degradation of the extracellular matrix. Doxycycline, a member of the tetracycline family of antibiotics, is a potent MMP inhibitor. We have previously shown doxycycline inhibits MMP activity and VSMC migration in vitro. We hypothesized that doxycycline would decrease MMP activity in vivo and inhibit the development of IH in a rodent model of vascular injury.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research, Basic Science Source Type: research
Intimal hyperplasia (IH) is the most common indicator for secondary intervention in peripheral vascular disease. Matrix metalloproteinases (MMPs) play a role in IH development due to their degradation of the extracellular matrix. Doxycycline (Doxy), a member of the tetracycline family of antibiotics, is a potent MMP inhibitor. We have previously shown that Doxy inhibits  MMP activity and vascular smooth muscle cell migration in vitro. We hypothesized that Doxy would decrease MMP activity in vivo and inhibit the development of IH in a rodent model of vascular injury.
Source: Annals of Vascular Surgery - Category: Surgery Authors: Tags: Clinical Research Source Type: research
A meta-analysis of randomized clinical trials concluded that there is an increased risk of death for patients treated with paclitaxel‐coated balloons and stents in the femoral and/or popliteal arteries of the lower limbs. At least two drug-eluting device trials have been paused since this analysis was published late last month in the Journal of the American Heart Association (JAHA). Investigators of the BASIL-3 trial and the SWEDEPAD 1 and SWEDEPAD 2 trials have paused recruitment efforts in response to the published findings. Konstantinos Katsanos, MD, PhD ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Business Source Type: news
CONCLUSIONS: The risk factors obtained from the medical history and during the hospitalisation improve the risk stratification during the post-discharge period after hospitalisation for ACS. PMID: 29350382 [PubMed - indexed for MEDLINE]
Source: Kardiologia Polska - Category: Cardiology Authors: Tags: Kardiol Pol Source Type: research
Publication date: Available online 14 October 2018Source: Journal of Cardiology CasesAuthor(s): Kuniyasu Ikeoka, Keita Okayama, Tetsuya Watanabe, Shinsuke Nanto, Yasushi Sakata, Shiro HoshidaAbstractA 47-year-old female patient was admitted with a complaint of severe chest pain on effort. She had a history of effort angina treated using coronary artery bypass with left internal thoracic arterial bypass to the left ascending coronary artery. She also had left subclavian and vertebral arterial stenoses, which were treated with balloon-expandable stents. Exercise stress myocardial perfusion imaging revealed anterior to apex l...
Source: Journal of Cardiology Cases - Category: Cardiology Source Type: research
CONCLUSIONS: Patients treated with DES had higher lesion and vessel patency than BMS after adjusting for confounding, which included complexity of lesion characteristics and operators' clinical decision-making regarding selection of treatment modalities, in femoropopliteal endovascular interventions in a real-world registry. PMID: 30279293 [PubMed - in process]
Source: The Journal of Invasive Cardiology - Category: Cardiology Tags: J Invasive Cardiol Source Type: research
Ra Medical yesterday set the terms for its forthcoming initial public offering, which would fetch $50 million at the midpoint. The Carlsbad, Calif.-based company said it plans to float 3.3 million shares at $14 to $16 apiece, for gross proceeds of $46.7 million to $53.3 million. At the midpoint the flotation would gross $50.0 million, according to a new filing with the U.S. Securities &Exchange Commission. That’s well below the more than $86 million Ra Medical indicated in a regulatory filing last month. The company makes the Dabra atherectomy catheter laser to treat patients with peripheral artery disease. ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Catheters Funding Roundup Initial Public Offering (IPO) Wall Street Beat peripheral Ra Medical Source Type: news
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