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Peripheral Arterial Articles & Analysis

42 news found

New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA

New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA

Xarelto is approved for more venous and arterial thromboembolic (VAT) conditions than any other NOAC: The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors The treatment of pulmonary embolism (PE) in adults The treatment of deep vein thrombosis (DVT) in adults The prevention of recurrent PE ...

ByBayer AG


An Easy, Predictable, and Simpler Way to Embolize Tumors

An Easy, Predictable, and Simpler Way to Embolize Tumors

Sawhney notes that as far back as the early days of Confluent Surgical, he had contemplated peripheral arterial embolization for the treatment of tumors, but at the time, decided against it. ...

ByInstylla, Inc.


Stanford Surgeon Venita Chandra Joins Alucent Biomedical Scientific Advisory Board as Company Enters Arteriovenous Fistula Market

Stanford Surgeon Venita Chandra Joins Alucent Biomedical Scientific Advisory Board as Company Enters Arteriovenous Fistula Market

Alucent is currently developing its Natural Vascular Scaffolding (Alucent NVS) Vessel Restoration System with Photoactivated Linking for the treatment of peripheral artery disease (PAD) of the lower extremities. The company announced today it will also seek to adapt the technology for another use, the maturation and preservation of arteriovenous fistula (AVF) for ...

ByAlucent Biomedical Inc.


Reva medical announces closing of strategic financing

Reva medical announces closing of strategic financing

“The funding we have secured will allow REVA to move forward with our pivotal clinical trial to support FDA approval of our MOTIV peripheral vascular scaffold as well as to obtain FDA clearance of our TyroSphere bioresorbable embolic bead technology.” REVA’s MOTIV device represents a unique breakthrough technology for the treatment of patients suffering from ...

ByReva Medical LLC


Instylla announces positive results from preclinical studies of Embraceâ„¢ Hydrogel Embolic System in hemorrhage models

Instylla announces positive results from preclinical studies of Embraceâ„¢ Hydrogel Embolic System in hemorrhage models

Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced two publications that evaluated the Embrace™ Hydrogel Embolic System (HES) in preclinical porcine hemorrhage models. ...

ByInstylla, Inc.


Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation

Rivaroxaban (Xarelto) approved in Japan for patients with peripheral artery disease (PAD) after revascularisation

The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with peripheral artery disease (PAD) after revascularization. The approval is based on data from the Phase III VOYAGER PAD trial. ...

ByBayer AG


Reva Medical Presents 6-Month Results from Motiv BTK Pilot Study

Reva Medical Presents 6-Month Results from Motiv BTK Pilot Study

The Company’s products include MOTIV bioresorbable scaffolds for the treatment of peripheral artery disease, Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease, and TyroSphere embolic beads. ...

ByReva Medical LLC


CARDIONOVUM announces the first Signature RCT patient enrollment

CARDIONOVUM announces the first Signature RCT patient enrollment

As Cardionovum® we are fully convinced that our LEGFLOW® DCB, with its unique coating Safepax® technology, will deliver to the patients the best results for the treatment of the peripheral arteries diseases.” ...

ByCARDIONOVUM GmbH


Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders To Address A Wide Range Of Peripheral Embolization Cases

Okami Medical Announces FDA 510(k) Clearance of the LOBO-7 and LOBO-9 Vascular Occluders To Address A Wide Range Of Peripheral Embolization Cases

The LOBO (LOw-profile Braided Occluder) system, purpose-built for fast and complete occlusion of a diverse set of peripheral arterial targets, now includes LOBO-3, LOBO-5, LOBO-7 and LOBO-9. ...

ByOkami Medical


Reva Medical Announces Final 5 Year Results for It’s Fantom II Coronary Scaffold Study

Reva Medical Announces Final 5 Year Results for It’s Fantom II Coronary Scaffold Study

The Company’s products include MOTIV bioresorbable scaffolds for the treatment of peripheral artery disease, Fantom and Fantom Encore bioresorbable vascular scaffolds for the treatment of coronary artery disease, and TyroSphere embolic beads. ...

ByReva Medical LLC


Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy

Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy

The Shockwave M5 and S4 IVL Catheters, which are used for the treatment of peripheral arterial calcification lesions, are approved in the United States, the European Union, and other select international jurisdictions and have been used to help treat more than 50,000 patients globally who suffer from peripheral arterial disease. ...

ByShockwave Medical Inc.


Shockwave IVL Maintains Superiority to Angioplasty in Calcified Peripheral Disease at Two Years

Shockwave IVL Maintains Superiority to Angioplasty in Calcified Peripheral Disease at Two Years

(NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that long-term data from the Disrupt PAD III trial found that superior vessel preparation with IVL led to excellent long-term outcomes out to two years with preservation of future treatment options compared to percutaneous transluminal angioplasty ...

ByShockwave Medical Inc.


Alucent Biomedical Announces First Patient Enrolled in First in Human Natural Vascular Scaffolding Clinical Trial

Alucent Biomedical Announces First Patient Enrolled in First in Human Natural Vascular Scaffolding Clinical Trial

The therapy is designed to open vessels and maintain patency without the use of permanent implants for the treatment of peripheral artery disease (PAD) of the lower extremities. PAD, a painful and debilitating condition, affects more than 200 million people globally. ...

ByAlucent Biomedical Inc.


Shockwave Medical Announces Global Launch of New Peripheral Intravascular Lithotripsy Catheter

Shockwave Medical Announces Global Launch of New Peripheral Intravascular Lithotripsy Catheter

(NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced the global commercial availability of the Shockwave M5+ peripheral IVL catheter after receiving both CE Mark and U.S. Food and Drug Administration (FDA) clearance. ...

ByShockwave Medical Inc.


Diffusion Pharmaceuticals Completes Phase 1b Study of TSC in Hospitalized COVID-19 Patients

Diffusion Pharmaceuticals Completes Phase 1b Study of TSC in Hospitalized COVID-19 Patients

The first study (the “TCOM Study”) will measure the effects of TSC on peripheral tissue oxygen delivery using a device called a transcutaneous oximeter, or TCOM. ...

ByCervoMed


ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

The BIOADAPTOR RCT is evaluating the DynamX™ Coronary Bioadaptor System, the first drug-eluting coronary artery implant that adapts to vessel physiology, allowing for the restoration of normal vessel functions essential to cardiovascular performance. ...

ByElixir Medical Corporation


U.S. FDA approves Xarelto to treat venous thromboembolism (VTE) and to prevent VTE in children

U.S. FDA approves Xarelto to treat venous thromboembolism (VTE) and to prevent VTE in children

Xarelto is the only Factor Xa anticoagulant FDA approved for pediatric patients and offers a flexible weight-based dosing Xarelto is available in both oral tablet and liquid suspension formulations for use in appropriate children less than 18 years of age Convenient liquid formulation advances standard of care for children; alleviates administration challenges found with injectable ...

ByBayer AG


CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR Antithrombotic Removal System During Urgent Cardiothoracic Surgery

CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR Antithrombotic Removal System During Urgent Cardiothoracic Surgery

Apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Janssen/Bayer) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients1 annually in the United States who are chronically on these medications to reduce the risk of deadly blood clots due to atrial fibrillation, prior history of heart attack or stroke, deep vein ...

ByCytoSorbents Corporation


Reflow Medical Receives Approval In Japan For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease

Reflow Medical Receives Approval In Japan For The Wingman Catheter To Cross Chronic Total Occlusions (CTOs) In Peripheral Artery Disease

Reflow Medical, Inc., a California- based medical device company, announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved the Wingman™ CTO Catheter. Reflow Medical has partnered with Century Medical, Inc. (CMI), a leading medical device distributor based in Tokyo, to introduce the Wingman CTO Catheter in Japan. The Wingman Catheter crosses peripheral ...

ByReflow Medical, Inc.


The long-term solution for stressed New York hearts

The long-term solution for stressed New York hearts

Beheshtian specializes in interventional cardiology and peripheral artery disease, providing top-quality heart care and promoting self-preventive cardiology. ...

ByCoala Life Inc.

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