Admedus (ASX:AHZ) dealt its biologic patch business to LeMaitre Vascular (NSDQ:LMAT) in a deal worth up to $24.6 million to focus on the transcatheter aortic valve replacement market. The A$36.2 million buyout of the CardioCel and VascuCel patches called for LeMaitre to put up $14.2 million up front, with another $1.4 million due in a pair […]
New FDA guidance out for vascular device labels
The FDA has issued two new final guidance documents governing labels for a variety of intravascular devices. One covers labels for intravascular catheters, wires, and delivery systems with lubricious coatings, and the other is for coronary, peripheral and neurovascular guidewires. Intravascular devices with hydrophilic or hydrophobic coatings may offer physicians greater maneuverability within blood vessels, and […]
AngioDynamics puts up $66m for Eximo Medical, cuts outlook
AngioDynamics (NSDQ:ANGO) said today that put up $66 million for Eximo Medical and its B-Laser peripheral atherectomy device and cut its fiscal 2020 earnings outlook to allow for the cost of launching the Eximo product. Latham, N.Y-based AngioDynamics said the deal for Eximo involved $46 million in up-front cash and another $20 million in technical and […]
Balt parent escapes Neurvana Medical sabotage suit
Balt International this week escaped a lawsuit brought by Neurvana Medical accusing Balt, its U.S. subsidiary and two executives of reneging on a $16 million deal for its Titan neurovascular catheter in scheme to “sabotage and destroy” Neurvana. In September 2016, the French company acquired Blockade Medical, including its Barricade coil and a facility in Irvine, […]
Covalon closes $6m private placement
Covalon Technologies (TSXV:COV.V) said yesterday that it closed a private placement worth nearly $6 million. Mississauga, Ontario-based Covalon initially priced the offering at about $6.3 million, but re-priced it to approximately $5.5 million earlier this month to reflect the market for its stock. The revised offering, of nearly 2.8 million units (one share and one warrant) […]
LimFlow wins FDA nod for pDVA trial in chronic limb-threatening ischemia
LimFlow said today that it won an investigational device exemption from the FDA for a pivotal trial of its catheter-based intervention for a severe form of peripheral artery disease. LimFlow’s percutaneous deep vein arterialization device is designed to re-route blood flow from a blocked artery through the venous system to deliver oxygenated blood to the […]
Orchestra BioMed wins breakthrough nod for Virtue SEB
Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. Get the full story […]
Biotronik taps Proximo Medical for U.S. peripheral debut
Biotronik tapped Proximo Medical to guide the U.S. commercialization of its peripheral vascular intervention platform. The German medtech maker’s PVI line includes the Pulsar and Astron stents, the Passeo PTA balloon catheter and Fortress introducer sheath. Castle Pines, Colo.-based Proximo provides market research services to medical device, venture capital and private equity companies. “By partnering […]
FDA clears Rex Medical’s Revolution peripheral atherectomy device
Rex Medical said last week that it received FDA 510(k) clearance for its Revolution peripheral atherectomy system. The Conshohocken, Pa.-based company’s Revolution device is indicated for atherectomy of the peripheral vasculature and is designed to break apart and remove thrombus from the peripheral arteries in patients with occlusive atherosclerotic disease. In the 121-person Reveal IDE […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to […]
Covalon re-prices offering to $5.5m
Covalon Technologies (TSXV:COV.V) said last week that it has re-priced its original non-brokered, private placement of $6.3 million to $5.5 million to reflect the current market price of its common shares. The revised offering will now include nearly 2.8 million units at $2 per unit, instead of the initial offer of 2.5 million units at […]
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