Reva Medical (ASX:RVA) has expanded its commercial operations into Switzerland, the company said today, with the first implant of its Fantom bioresorbable scaffold. The scaffold is made from Reva’s tyrosine-derived, radiopaque polymer, rendering Fantom visible under fluoroscopy – a characteristic that is unique to Reva’s product. Get the full story at our sister site, Drug Delivery […]
Reva Medical Inc.
European task force: Docs should favor drug-eluting stents over bioresorbable scaffolds
Physicians should not use bioresorbable scaffolds in place of current-generation drug-eluting stents, according to a report from the European Society of Cardiology and European Association of Percutaneous Cardiovascular Inventions. The ECS/EAPCI report says that as long as concerns remain about the increased risk of myocardial infarction and scaffold thrombosis linked with bioresorbable scaffolds, physicians should […]
Reva Medical’s Fantom bioresorbable, drug-eluting vascular scaffold succeeds at 6 months
As some companies have worked to improve drug-eluting stents by making them bioresorbable, some voices in the coronary intervention space have expressed concern over the rates of late stent thrombosis and repeat percutaneous coronary intervention seen with the devices. In a study published in the September issue of JACC: Cardiovascular Intervention, Reva Medical‘s (ASX:RVA) Fantom coronary bioresorbable […]
Reva Medical pursues direct-sales after Boston Scientific distro negotiation deal lapses
Reva Medical (ASX:RVA) said today it will take up direct marketing of its peripheral and vascular scaffolds after Boston Scientific‘s (NYSE:BSX) right to negotiate for exclusive distribution of the products expired. San Diego, Calif.-based Reva said that Boston Scientific had gained the right to negotiate for exclusive distribution rights under a 2007 agreement which would have positioned […]
Reva closes $35m financing round
Reva Medical (ASX:RVA) said today that it closed the 2nd tranche of its $34.6 million financing round. The company issued $47.1 million convertible notes, 2,119,500 options for the purchase of common stock and repurchased $12.5 million of its common stock from 1 unnamed investor. The San Diego, Calif.-based company’s 1st commercial product is its Fantom sirolimus-eluting […]
EuroPCR Roundup: Medtronic’s Resolute Onyx meets primary endpoint in small-vessel trial
Medtronic‘s (NYSE:MDT) Resolute Onyx 2.0mm drug-eluting stent met its primary endpoint of target lesion failure at 1 year for the treatment of coronary artery disease in extra-small vessels, according to data from the Resolute Onyx 2.0mm trial. The trial enrolled 101 patients with extra-small vessel sizes ranging from 2 millimeters to 2.25 millimeters. Patients treated with […]
Reva plans $40m convertible note offering
Reva Medical (ASX:RVA) said yesterday that it’s planning a $40 million convertible note offering with several institutional and 1 undisclosed corporate investor to fund the company’s ongoing needs, including the clinical development of its Fantom sirolimus-eluting bioresorbable coronary scaffold. Upon issuance of the convertible notes, the company is slated to receive $32.5 in net cash […]
Reva Medical wins CE Mark for Fantom bioresorbable scaffold
Reva Medical (ASX:RVA) said yesterday that it won CE Mark approval in the European Union for its Fantom sirolimus-eluting bioresorbable coronary scaffold. The Fantom scaffold is the San Diego, Calif.-based company’s 1st commercial product. Reva said it plans to begin selling the product in Europe this quarter. Get the full story at our sister site, Drug Delivery […]
Reva Medical looks to CE Mark for Fantom scaffold
Reva Medical (ASX:RVA) said today it completed its submission for CE Mark approval of its Fantom sirolimus-eluting bioresorbable coronary scaffold following the completion of a clinical data analysis and testing. The San Diego, Calif.-based company said it is hopeful it will receive CE Mark approval by December 31, 2016. Data from a 117-patient cohort from its […]
EuroPCR 2016 Update: TAVR innovations, FFR systems in the spotlight
UPDATED May 20, 2016, with more results out of Paris. St. Jude Medical (NYSE:STJ) announced it won CE Mark approval in the European Union for its PressureWire X Guidewire fractional flow reserve measurement system and is launching the product in Europe. The company announced the launch and clearance at the EuroPCR meeting in Paris this week. […]
Nevro promotes prez Elghandour to replace CEO DeMane | Personnel Moves
Nevro Corp. (NYSE:NVRO) this week promoted president Rami Elghandour to be its new CEO, as chief executive Michael DeMane moves to the executive chairman spot. DeMane, the former COO at Medtronic, will keep an active role in Nevro, which he joined in 2011 after a quickly aborted stint at the head of Lanx. He’s due to […]