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Home » Authors » Shani Alexander

Articles by Shani Alexander

Sequana---Alfapump,-Cathether,-charger.jpg

Sequana considers listing in the US as it looks for growth for Alfapump

May 24, 2023
By Shani Alexander
Sequana Medical NV is considering listing in the U.S. as it builds towards the commercialization of its Alfapump, CEO Ian Crosbie told BioWorld in an interview. The company has received a U.S. FDA breakthrough device designation for Alfapump, which treats recurrent or refractory ascites due to liver cirrhosis, and it completed a pivotal study in 2022. The company intends to file the data with the FDA by the end of this year, with the hope of getting premarket approval before the end of 2024.
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R-One+-work-station-and-robotic-unit.jpg
EuroPCR 2023

Robocath launches Robotic platform for cardiology as Siemens drops business

May 22, 2023
By Shani Alexander
Robocath SAS is about to embark on a limited market release of its robotic platform, the R-One+, which will not only make performing coronary angioplasties easier and safer but will protect cardiologists from radiation, CEO Lucien Goffart told BioWorld in an interview. However, the launch comes on the heels of a decision by Siemens Healthineers Inc. to discontinue its robotic-assisted endovascular cardiology business as it did not meet the company’s “initial expectations.”
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Clinical data illustration
EuroPCR 2023

Medtronic, Philips, Edwards late-breaking study data spotlighted at EuroPCR

May 19, 2023
By Shani Alexander
Among the many companies presenting data at the EuroPCR conference in Paris, several late breaking trials from heavy hitters Medtronic plc, Royal Phillips NV and Edwards Lifesciences Corp. stood out.
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Stent illustration
EuroPCR 2023

GE Healthcare launches 3Dstent imaging tool

May 18, 2023
By Shani Alexander
GE Healthcare Technologies Inc. launched a 3Dstent imaging tool at the EuroPCR conference in Paris which it said will allow a new perspective on stent visualization, helping doctors do a better job. The company warned however that it is still in the process of validating the technology, which complements existing technologies and provides intraprocedural 3D and multi-slice images of stent but has certain limitations.
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Heartpoint-Intellistent-system.jpg
EuroPCR 2023

Heartpoint Global preparing to begin human trials for Intellistent

May 18, 2023
By Shani Alexander
Heartpoint Global Inc. will begin human trials of its Intellistent device shortly and expects to make submission to the U.S. FDA in 2024, Seth Bogner, its chairman and CEO told BioWorld in an interview on the sidelines of the EuroPCR conference in Paris. Intellistent is a multi-lumen stent system for interventional adjustment of pulmonary blood flow in congenital heart disease. It is a minimally invasive device that will meet an unmet need in pulmonary artery hypertension caused by congenital heart disease, said Bogner.
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Elixir-Medical----DynamX-expanded-in-vessel.jpg
EuroPCR 2023

Elixir study shows that Dynamx is not inferior to Resolute Onyx

May 17, 2023
By Shani Alexander
Elixir Medical Corp. reported that the Bioadaptor randomized controlled trial which compared its Dynamx coronary drug-eluting bioadaptor system to Dublin-based Medtronic plc’s Resolute Onyx drug-eluting stent (DES) in de novo native coronary arteries, met its primary endpoint of target lesion failure (TLF) non-inferiority at 12 months. The results were presented at a late-breaking clinical session during the EuroPCR 2023 conference in Paris.
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4-9-Abbott-Triclip.png
EuroPCR 2023

Abbott reports new late-breaking data that adds to benefit of Triclip

May 17, 2023
By Shani Alexander
Abbott Laboratories Inc. reported late-breaking data from the Bright study which showed that its Triclip transcatheter edge-to-edge repair (TEER) system reduced tricuspid regurgitation and improved the quality of life of patients with leaky tricuspid valves. The results from the largest real-world dataset were presented, for the first time, at the EuroPCR 2023 conference in Paris.
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EuroPCR

Studies show that 2 stents are not necessary in bifurcation diseases

May 16, 2023
By Shani Alexander
It has become apparent that introducing two stents into the body to treat a patient with a bifurcation disease is not necessary and can be harmful, David Hildick-Smith, the lead investigator in a study, told delegates at the EuroPCR conference in Paris. Presenting late-breaking clinical data of three-year follow up results of different stenting strategies in patients with true left main stem bifurcation lesions, Hildick-Smith said that the results showed that only one in five patients needed a second stent.
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Hygh-tec-transanal-sealing.jpg

Advanced Medical Balloons brings Hygh-tec stool drainage system to the US

May 11, 2023
By Shani Alexander
Creative Balloons GmbH has changed its name to Advanced Medical Balloons GmbH and is bringing its fecal management system, Hygh-tec, to the U.S. market after receiving clearance from the U.S. FDA. Hygh-tec is a microscopically thin polyurethane balloon catheter system which enables reliable, sealed access to the colon preventing fecal leakage from patients in intensive care units.
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LSX World Congress

European med-tech companies first looking to the US as EU MDR ‘not working’

May 10, 2023
By Shani Alexander
An increasing number of European med-tech companies are first seeking regulatory approval from the U.S. FDA because of the growing backlog and frustrations with requirements under the new regulatory framework of the EU Medical Device Regulation (MDR), which has been described as “not working.”
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