Boston Scientific Touts Positive Data on Two Paclitaxel Devices

Boston Scientific announced positive data Tuesday for two paclitaxel devices during separate late-breaking clinical trial presentations at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for the drug-coated balloon manufacturers and physicians this year, but presentations like these could go a long way toward helping the market rebound. To recap, paclitaxel balloons and stents received some bad press in late December 2018 after a meta-analysis showed an increased risk of death for patients treated with these devices. FDA held a two-day meeting of the Circulatory System Devices Panel in June, and concluded at the meeting that there is a signal associated with an increase in mortality through five years of paclitaxel-coated (or eluting) devices compared to non-coated devices. The agency was not, however, able to attribute this increased risk to a specific cause, and the committee was befuddled by data discrepancies. FDA eased up on recommendations regarding paclitaxel devices in August, but by that time the issue had already driven a market decline of about 50%.   Good News for Eluvia Data presented this week at VIVA included a 12-month interim analysis from the RANGER II SFA trial of the Ranger drug-coated balloon (DCB) as well as 24-month results from the ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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End-stage renal disease (ESRD) patients experiencing kidney failure typically require hemodialysis in order to artificially remove fluid and waste from blood and maintain appropriate electrolyte concentrations. For many patients on hemodialysis, an a...
Source: Medgadget - Category: Medical Devices Authors: Tags: Exclusive Medicine Vascular Surgery Source Type: blogs
Paclitaxel-coated balloons and paclitaxel-eluting stents caused quite the stir for manufacturers and physicians this year, but an FDA approval this week marks a major step forward for this category of devices. The agency approved Medtronic's IN.PACT AV drug-coated balloon for the treatment of failing arteriovenous access in patients with end-stage renal disease (ESRD) undergoing dialysis. AV fistulae are created and used to enable hemodialysis for patients with ESRD. Over time, vessel restenosis limits the ability to use AV fistulae effectively. In order to restore function, patients often undergo one to three ...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
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: bizjournals.com Health Care:Pharmaceuticals headlines - Category: Pharmaceuticals Authors: Source Type: news
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 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
SurModics (NSDQ:SRDX) said today it inked a deal with Embolitech to acquire its thrombectomy platform the and associated intellectual property in a deal worth $5 million up front, with additional payments based on regulatory milestones. The newly acquired tech platform is designed for use in the peripheral vasculature to remove hard blood clots, Eden Prairie, Minn.-based SurModics said. SurModics added that it plans to leverage its design, development and manufacturing capabilities to advance the platform into different peripheral and vascular applications. “We are pleased to sign an agreement with Surmodic...
Source: Mass Device - Category: Medical Devices Authors: Tags: Business/Financial News Catheters Mergers & Acquisitions Vascular SurModics Inc. Source Type: news
Medtronic is entering  a bold new chapter in the continued evolution of its drug-coated balloon technology (DCB). The Dublin-based firm said on Monday, that it received a nod from FDA for the IN.PACT Admiral DCB to treat long superficial femoral artery (SFA) lesions up to 360mm in patients suffering from peripheral artery disease (PAD).  Approval was based on clinical data from the complex lesion imaging cohorts of the IN.PACT Global Study, including long lesion, in-stent restenosis, and chronic total occlusion groups with lesion lengths greater than 180mm. Across these groups, a total of 227 subjects with mean l...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news
Abstract The Chocolate BAR study is a prospective multicenter post‐market registry designed to evaluate the safety and performance of the Chocolate percutaneous transluminal angioplasty balloon catheter in a broad population with symptomatic peripheral arterial disease. The primary endpoint is acute procedural success (defined as ≤30% residual stenosis without flow‐limiting dissection); secondary long‐term outcomes include freedom from target lesion revascularization (TLR), major unplanned amputation, survival, and patency. A total of 262 patients (290 femoropopliteal lesions) were enrolled at 30 US centers betwee...
Source: Catheterization and Cardiovascular Interventions - Category: Cardiovascular & Thoracic Surgery Authors: Tags: Peripheral Vascular Disease Source Type: research
Background— Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. Methods and Results— IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral...
Source: Circulation: Cardiovascular Interventions - Category: Cardiology Authors: Tags: Peripheral Vascular Disease Source Type: research
Conclusions This NMA demonstrated that DCB provided better reduction in TLR rates compared with PTA and BMS.
Source: Journal of Vascular and Interventional Radiology - Category: Radiology Source Type: research
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