Orchestra 's Drug-Eluting Balloon Wins FDA Breakthrough Device Designation

FDA has granted a breakthrough device designation for Orchestra BioMed's Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee (BTK) peripheral artery disease. The designation comes just a few months after the New Hope, PA-based announced its partnership with Terumo. The agreement included a $30 million up-front payment to Orchestra plus an equity commitment of $5 million. Virtue SEB is a novel, first-in-class drug/device combination product that delivers a sustained-release sirolimus formulation directly to the artery during balloon angioplasty without the need for a coating. Breakthrough device designation is granted to medical devices and device-led combination products that provide the potential for a more effective treatment option for life-threatening or irreversibly debilitating diseases. The pathway is intended to expedite the review process. “Virtue SEB’s unique design enables delivery of sustained-release sirolimus during angioplasty without the need for coating or permanent implant. This highly differentiated design makes this product the ideal candidate for breakthrough device designation in BTK peripheral artery disease,” said James Zidar, MD, a clinical professor of medicine at UNC Health Systems, and physician-in-chief at Heart &Vascular Corporate. “Currently, there is a significant unmet need in the BTK stenosis treatment landscap...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news

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AbstractObjectivesCentral or peripheral venoarterial extracorporeal membrane oxygenation (va ECMO) is widely used in postcardiotomy cardiogenic shock (PCS). Available data suggest controversial results for both types. Our aim was to investigate PCS patients treated with either peripheral (pECMO) or central ECMO (cECMO) concerning their outcome.MethodsBetween April 2006 and October 2016, 156 consecutive patients with va ECMO therapy due to PCS were identified and included in this retrospective analysis. Patients were divided into cECMO and pECMO groups. Statistical analysis of risk factors concerning 30 ‐day mortality of ...
Source: Journal of Cardiac Surgery - Category: Cardiovascular & Thoracic Surgery Authors: Tags: ORIGINAL ARTICLE Source Type: research
(American College of Cardiology) The results of VOYAGER PAD found that people with peripheral artery disease (PAD) who took the blood thinner rivaroxaban with aspirin after undergoing lower extremity revascularization -- a procedure to treat blocked arteries in the leg -- had a significant reduction in the risk of major adverse limb and cardiovascular events when compared with those receiving aspirin alone, according to a subgroup analysis from VOYAGER PAD presented at the American College of Cardiology's Annual Scientific Session Together with World Congress of Cardiology (ACC.20/WCC).
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
The new vascular low dose of rivaroxaban has gotten off to a slow start, but these new subgroup results may stimulate use in patients with diabetes and stable coronary or peripheral artery disease.Medscape Medical News
Source: Medscape Cardiology Headlines - Category: Cardiology Tags: Cardiology News Source Type: news
Conclusions: In statin-treated patients with recent ACS, risk of PAD events is related to lipoprotein(a) level and is reduced by alirocumab, particularly among those with high lipoprotein(a). Further study is required to confirm whether risk of VTE is related to lipoprotein(a) level and its reduction with alirocumab. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01663402. PMID: 32223446 [PubMed - as supplied by publisher]
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
RARITAN, NJ, March 28, 2020 – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced the VOYAGER PAD study met its primary efficacy and principal safety endpoints, demonstrating the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily) plus aspirin (100 mg once daily) was superior to aspirin alone in reducing the risk of major adverse limb and cardiovascular (CV) events by 15 percent in patients with symptomatic peripheral artery disease (PAD) after lower-extremity revascularization, with similar rates of TIMI[1] major bleeding. VOYAGER PAD is the only study to show a significant benefit...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
AbstractPurposeTo investigate risk factors for severe bleeding during warfarin treatment, including the influence of sex, age, comorbidity and co-medication on bleeding risk.MethodsPatients initiating warfarin treatment between 2007 and 2011 were identified in the nationwide Swedish Prescribed Drug Register, and diagnoses of severe bleeding were retrieved from the National Patient Register. Hazard ratios (HR) with 95% confidence intervals (CI) for severe bleeding were estimated using multiple Cox regression adjusting for indications and including covariates age, sex, comorbidities and co-medications. Interactions between s...
Source: European Journal of Clinical Pharmacology - Category: Drugs & Pharmacology Source Type: research
New England Journal of Medicine, Ahead of Print.
Source: New England Journal of Medicine - Category: Internal Medicine Authors: Source Type: research
nd Investigators Abstract Background: Patients with established coronary artery disease (CAD) or peripheral artery disease (PAD) often have diabetes mellitus. These patients are at high risk of future vascular events. Methods: In a prespecified analysis of the COMPASS trial, we compared the effects of rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg daily) versus placebo plus aspirin in patients with diabetes versus without diabetes in preventing major vascular events. The primary efficacy endpoint was the composite of cardiovascular death, myocardial infarction (MI), or stroke. Secondary endpoints included a...
Source: Circulation - Category: Cardiology Authors: Tags: Circulation Source Type: research
Xarelto™ 2.5 mg plus aspirin significantly lowered the combined risk of limb ischemia and major cardiovascular events in patients with symptomatic peripheral artery disease post revascularizationThe only clinical outcome study to demonstrate the benefits of a combined antithrombotic and anti-platelet therapy in these vulnerable patients who currently have limited treatment options / Risk of acute limb ischemia was significantly reduced by 33% in these patients compared to those receiving aspirin alone / There was no significant increase in TIMI major bleeding, the principal safety outcome of the trialmehr ...
Source: Bayer IR Newsfeed: Events - Category: Pharmaceuticals Source Type: news
Purpose: Many patients with ischemic stroke have concomitant coronary artery disease (CAD). However, it remains unclear which stroke patients should undergo evaluation for asymptomatic CAD, and which screening tools are appropriate. We investigated the role of coronary artery calcium (CAC) score as a screening tool for asymptomatic but severe CAD in acute stroke patients. We determined the selection criteria for CAC screening based on risk factors and cerebral atherosclerosis.Materials and Methods: The present study included consecutive patients with acute stroke who had undergone cerebral angiography and multi-detector co...
Source: Frontiers in Neurology - Category: Neurology Source Type: research
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