Peripheral/Endo

NEW DATA DEMONSTRATES SAFETY AND PERFORMANCE OF CONTINUOUS ASPIRATION THROMBECTOMY WITH PENUMBRA’S INDIGO® SYSTEM CAT™ RX CATHETER IN HIGH-RISK PATIENTS WITH ACUTE CORONARY SYNDROME

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CAT RX established high rates of blood clot removal, blood flow restoration and myocardial perfusion normalization No serious adverse events associated with the use of sustained power aspiration Results of the CHEETAH clinical study were presented at the 2021 Transcatheter Cardiovascular Therapeutics (TCT) conference     ALAMEDA, Calif. – November 5, 2021 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, announced that the CHEETAH clinical study of its Indigo® System CATTM RX Catheter successfully met the primary endpoint and […]

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InspireMD Announces Publication of 12-Month Results of CGuard™ EPS SIBERIA Trial in Journals of the American College of Cardiology: Cardiovascular Interventions

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TEL AVIV, Israel, Nov. 03, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced that results from the investigator-initiated SIBERIA randomized clinical trial of CGuard EPS, that […]

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Vascular Therapies Announces Presentation of Phase 3 Clinical Trial Results at the American Society of Nephrology Meeting

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– Sirogen™ Shows Encouraging AV Fistula Outcomes in Elderly End-Stage Renal Disease Patients – CRESSKILL, N.J., Nov. 4, 2021 /PRNewswire/ — Vascular Therapies, a privately held biotechnology company is developing Sirogen™, a proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. Today, the company announced the presentation […]

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FDA Clears 12 New XO Cross Microcatheters

Peripheral/Endo Regulatory by 0 comments

12 new hydrophilic-coated micro and support catheters cleared by FDA for broad use in the peripheral vasculature. PARK CITY, Utah, Nov. 2, 2021 /PRNewswire/ — Transit Scientific announced the FDA clearance of new hydrophilic-coated XO Cross Microcatheters for guidewire support, exchange, and contrast media injection in the peripheral vasculature. “The XO Cross devices […]

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Inari Medical Announces 6-month FLASH Registry Interim Data Demonstrating Benefits of Lytic-Free Mechanical Thrombectomy in 500 Real-World PE Patients

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IRVINE, Calif., Oct. 28, 2021 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, today announced positive acute and long-term interim results from the first 500 pulmonary embolism (“PE”) patients […]

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Use of a Novel, Intermittent Pneumatic Compression Device to Promote Perforator Vein Dilation in Patients with Chronic Renal Failure: The pFACT Trial

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October 2021 ISSN 2152-4343 Abstract Objective. Arteriovenous fistula (AVF) creation is an important procedure for hemodialysis in chronic renal failure (CRF) patients. Recent advancements in vascular access have resulted in endovascular AVF (endoAVF) creations. EndoAVFs are less invasive and less expensive when placed. The dilation of the perforator vein pre-procedure is crucial […]

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Inari Medical Announces Randomized Controlled Trial Evaluating Clinical Outcomes of the FlowTriever® System in Pulmonary Embolism Patients

Peripheral/Endo Radiology by 0 comments

IRVINE, Calif., Oct. 18, 2021 (GLOBE NEWSWIRE) — Inari Medical, Inc. (NASDAQ: NARI) (“Inari”) a medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases, announced planned enrollment of the PEERLESS trial. PEERLESS is a new randomized controlled trial (RCT) comparing […]

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InspireMD Receives Reimbursement Approval for CGuard™ Embolic Prevention System from the French National Authority for Health

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TEL AVIV, Israel, Oct. 13, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), a global developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announced that its CGuard EPS stent system has received a positive opinion from […]

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18-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR™ Presented as Late Breaking Trial at VIVA

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GENEVA, Oct. 8, 2021 /PRNewswire/ — 18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been presented as a Late Breaking Clinical Trial at VIVA21. The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions […]

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Venclose MAVEN Earns FDA Clearance to Treat Incompetent Perforator Veins

Peripheral/Endo Regulatory by 0 comments

Next-generation radiofrequency catheter offers first thermal ablation perforator treatment advancement in over 10 years SAN JOSE, Calif., Oct. 7, 2021 /PRNewswire/ — Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease today announced FDA 510(k) clearance for Venclose Maven™, a novel radiofrequency ablation […]

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