Endologix today announced that it has launched its Alto abdominal stent graft system in Europe. The first implant of the stent graft took place in Stevenage, England, following the company's recent CE mark approval. The device was chosen for that specific patient because of their short, thrombus-lined conical aortic neck. “We are pleased to … [Read more...] about Endologix launches abdominal stent graft in Europe
Micro Medical gains CE Mark for stent and balloon
Micro Medical this week announced that it received CE Mark approval for its long over-the-wire balloon catheter and MicroStent vascular stent. MicroStent and MicroBalloon XL are part of the company's MMS Micro Vascular Integrated Platform and are designed to achieve and maintain vessel latency and improve blood flow to reduce below-the-knee … [Read more...] about Micro Medical gains CE Mark for stent and balloon
Vascular Graft Solutions wins innovative device designation in China
Vascular Graft Solutions recently announced that its Vest external stent received innovative medical device designation from the China National Medical Products Administration. The Vest external stent is designed for vein grafts in coronary artery bypass surgery. It has been proven to mitigate the underlying factors leading to vein grafts … [Read more...] about Vascular Graft Solutions wins innovative device designation in China
Medtronic Resolute Onyx stent gains expanded FDA clearance
Medtronic today said it received FDA clearance for an expanded indication of its Resolute Onyx drug-eluting stent (DES). The new indication allows for one-month of dual-antiplatelet therapy (DAPT) labeling with an expanded indication for high bleeding risk patients that are implanted with the device. Resolute Onyx is the only DES in the U.S. … [Read more...] about Medtronic Resolute Onyx stent gains expanded FDA clearance
Teleflex wins FDA clearance for EZ-IO intraosseous vascular access system expanded indications
Teleflex today said it received FDA 510(k) clearance for expanded indications of its Arrow EZ-IO intraosseous vascular access system. The device is designed to be used when intravenous access is difficult or impossible to obtain in emergent, urgent or medically necessary cases. The expanded indication allows the device to be used for up to 48 … [Read more...] about Teleflex wins FDA clearance for EZ-IO intraosseous vascular access system expanded indications
W. L. Gore debuts lower-profile endoprosthesis
W.L. Gore this week announced it has launched its lower profile, large diameter Gore ViaBahn Endoprosthesis. The device design reduces the delivery profile for larger 9-13 mm diameter stent grafts by up to 3 Fr to enable delivery through smaller sheaths. The smaller introducer sheaths result in a lower risk of vascular access complications and … [Read more...] about W. L. Gore debuts lower-profile endoprosthesis
BioProtect closes $25M Series D equity financing round
BioProtect this week announced it closed a $25 million Series D equity financing round. Peregrine Ventures and an unnamed strategic investor completed the financing round that was led by Almeida Ventures and Vincent Tchenguiz, chairperson of Consensus Business Group. KB Investments of South Korea and Triventures also participated in the … [Read more...] about BioProtect closes $25M Series D equity financing round
Acutus Medical 3D imaging and mapping catheter wins FDA clearance
Acutus medical recently won FDA 510(k) clearance of its AcQMap 3D imaging and mapping catheter. The mapping catheter builds on its predecessor and improves handling and deliverability. It combines 48 ultrasound transducers responsible for creating anatomical geometry and 48 engineered electrodes that enable electrical activation patterns to … [Read more...] about Acutus Medical 3D imaging and mapping catheter wins FDA clearance
Prytime Medical launches aortic occlusion catheter
Prytime Medical recently launched its aortic occlusion catheter ER-REBOA Plus Catheter. The resuscitative endovascular balloon occlusion of the aorta (REBOA) catheter is designed for controlling massive non-compressible hemorrhage. “ER-REBOA Plus represents the evolution of REBOA based on experience and input from civilian trauma surgeons,” … [Read more...] about Prytime Medical launches aortic occlusion catheter
FDA clears Avinger image-guided CTO crossing system
Avinger this week announced it received FDA 510(k) clearance for its Ocelaris image-guided chronic total occlusion crossing system. The device will be marketed under the brand name TigerEye and will provide real-time imaging from inside the vessel during CTO-crossing procedures. “We are excited to receive U.S. pre-marketing clearance for … [Read more...] about FDA clears Avinger image-guided CTO crossing system
