Tag: peripheral artery disease
Cardiovascular Systems announces launch of Peripheral Orbital Atherectomy System outside the...
Cardiovascular Systems Inc. (CSI), a medical device company developing and commercialising interventional treatment systems for patients with peripheral and coronary artery disease, has announced...
Avinger announces 510(k) filing of Pantheris Small Vessel device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the Company submitted a new 510(k) application to the US Food &...
PAD catheter effective in all lesion types receives FDA clearance
XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the US Food and Drug Administration...
First patients treated with Avinger’s next generation atherectomy device
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The...
Serranator PTA serration balloon catheter receives CE mark
Cagent Vascular has announced the issuance of its CE marking for the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. Cagent Vascular has also achieved...
Shockwave Medical Lithoplasty system launched in USA as first patient enrolled...
Shockwave Medical has announced two milestones for its Lithoplasty system for the treatment of calcified plaque in patients with peripheral artery disease (PAD): enrolment...
Avinger announces positive two year data from pivotal VISION study of...
Avinger has announced positive two-year clinical data from the pivotal VISION study of the company’s Lumivascular technology. Twenty-four-month follow-up results from 89 patients were...
Ra Medical Systems receives US FDA clearance for DABRA peripheral artery...
The US Food and Drug Administration (FDA) has granted market clearance to Ra Medical Systems—makers of excimer lasers and catheters for cardiovascular and dermatological...
Contego Medical receives CE mark for Vanguard IEP peripheral balloon angioplasty...
Contego Medical has announced that it has received CE mark for its Vanguard IEP peripheral balloon angioplasty system with integrated embolic protection. The company...
Consistent results for Medtronic IN.PACT Admiral in complex peripheral artery disease...
Two new sub-analyses from the IN.PACT Global Study of the IN.PACT Admiral in patients with peripheral artery disease have been reported at the annual...
First US patient treated in vascular study of Shockwave Medical Lithoplasty...
PinnacleHealth CardioVascular Institute has enrolled the first US patient in a trial assessing the safety and effectiveness of a new type of approach for...
Intact Vascular completes enrolment in TOBA II clinical trial
Intact Vascular’s TOBA II (Tack optimized balloon angioplasty II) clinical trial has completed enrolment. A total of 210 patients have been enrolled in TOBA II at 33 sites...
Smartphone over treadmill: Mapping claudication with Google Maps
The use of GPS mapping tools has become a cornerstone of modern life. A study published by the Journal of Vascular Surgery has demonstrated...
PQ Bypass announces CE mark for Detour percutaneous bypass technologies
PQ Bypass has announced CE mark approval for a trio of proprietary devices: the Torus stent graft system, PQ Snare, and PQ Crossing Device,...
Eyes may hold clues to future narrowing of leg vessels
Changes in tiny blood vessels of the eye may predict a higher risk of later narrowing in the large blood vessels in the legs,...
Tigris stent gets Health Canada approval for peripheral artery disease
Gore has announced the Health Canada approval of the Tigris vascular stent, a dual-component stent with a unique fluoropolymer/nitinol design. The device, which gained...
Last patient enrolled in SB-030 SHIELD trial for peripheral artery disease...
Symic Bio, has completed enrolment for the SHIELD clinical trial of SB-030 in peripheral artery disease. The trial will evaluate the safety and efficacy...
Medtronic announces Health Canada licence for IN.PACT Admiral drug-coated balloon
Medtronic Canada, a subsidiary of Medtronic, has announced it has obtained Health Canada licence for the IN.PACT Admiral drug-coated balloon. IN.PACT Admiral is a primary...
First implant of Viabahn VBX stent graft completed
Houston Methodist Hospital has become the first US institution to implant the newly FDA-approved Viabahn VBX balloon expandable endoprosthesis (VBX stent graft; Gore), to...
US National Institutes of Health grant US$1.5m for peripheral artery disease...
Profusa and North Carolina State University's ASSIST Center (Raleigh, USA) have announced that their collaboration to develop an ultrathin flexible-patch reader worn on the...
Medtronic receives CE mark for lower-profile HawkOne directional atherectomy system
Medtronic has been granted CE mark approval for the HawkOne directional atherectomy system in a lower profile size for treating patients with peripheral artery...
Intact Vascular closes on additional funding to advance development of Tack...
Current Intact Vascular investors—New Enterprise Associates, Quaker Partners and HIG BioHealth Partners—have exercised their right to invest additional capital as part of the company’s...
Humacyte commences US phase II arterial bypass clinical trial
Humacyte has announced the initiation of a US phase II arterial bypass clinical trial of Humacyl, an investigational human acellular vessel, to test its safety...
Stellarex ILLUMENATE 12-month pivotal results are “top-tier” in complex patients
Spectranetics has announced that the final 12-month results of the Stellarex drug-coated balloon ILLUMENATE pivotal trial have been presented at the Transcatheter Cardiovascular Therapeutics...
Spectranetics files FDA pre-market approval application for the Stellarex drug-coated balloon
Spectranetics has submitted its pre-market approval application for the Stellarex drug-coated angioplasty balloon to the US Food and Drug Administration (FDA). Stellarex is designed to restore...
Shockwave Medical announces plans for “largest ever” calcified peripheral artery disease...
Shockwave Medical has announced plans for DISRUPT PAD III—what is claims is the “largest ever” multicentre randomised study to exclusively enrol patients with calcified...
FDA approves TOBA II BTK pivotal IDE clinical study
The US Food and Drug Administration (FDA) has granted staged approval for Intact Vascular’s investigational device exemption (IDE) application to begin its TOBA II BTK...
Avinger granted expanded US FDA indications for Pantheris image-guided atherectomy device
Avinger has received expanded indications from the US Food and Drug Administration (FDA) recognising the Pantheris lumivascular atherectomy system as a technology that can be...
The use of robotics in peripheral artery disease interventions
Despite significant advances in pharmacotherapy and device technology for percutaneous cardiovascular interventions, the fundamental technique of manually advancing intravascular devices at the patient’s table...
New SVS peripheral artery disease reporting standards announced
The Society for Vascular Surgery has released new reporting standards focused on endovascular treatment of chronic lower extremity peripheral artery disease. Recommended reporting standards...
Lutonix Global Real-World Registry 24-month outcomes presented at VIVA 2016
Bard has announced the presentation of the final 24-month results from the Lutonix Global Real-World Registry at the Vascular Intervention Advances (VIVA) 2016 meeting...
FDA approves six-month primary endpoint for the Lutonix below-the-knee drug-coated balloon
The US Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint to a six-month...
CardioVascular Coalition urges increased awareness of peripheral artery disease in September
The CardioVascular Coalition (CVC)—a group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness,...
