C.R. Bard (NYSE:BCR) has notified buyers of its LifeStream covered iliac stent of a higher-than-anticipated restenosis rate among patients. The field notice issued by Bard, parent company BD and Irish catheter-maker ClearStream Technologies said the restenosis rate of 0.04% exceeds the acceptable failure rate of 0.01%. An unspecified number of restenosis complaints was reported following implantation of […]
Vascular Therapies raises $12m for drug-eluting vascular access implant
Vascular Therapies has raised $12.4 million from 29 investors as part of a $21.1 million round, according to a document filed last week with the SEC. The Cresskill, N.J.-based company is developing a sirolimus-eluting collagen implant for patients with end-stage renal disease. The bioresorbable drug-delivery system is designed to keep open a portal of entry […]
FDA: Endologix recall of AFX stent graft is Class I
Endologix (NSDQ:ELGX) said late last week that the FDA classified its voluntary recall of AFX Endovascular abdominal aortic aneurysm stent graft systems as Class I. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The […]
Teleflex picks up Essential Medical and its Manta vascular closure device
Teleflex (NYSE:TFX) said yesterday that it acquired Essential Medical and its Manta vascular closure device for an unspecified amount. Manta is designed to close punctures at femoral arterial access sites after catheterization procedures, including transcatheter aortic valve replacements, endovascular treatment of abdominal aortic aneurysms, ventricular assist procedures and balloon aortic valvuloplasties. Exton, Pa.-based Essential won CE Mark approval in the […]
V-Wave launches pivotal interatrial shunt trial
V-Wave said today it launched a new trial of its minimally invasive interartrial shunt designed to treat patients with symptomatic heart failure. The new Relieve-HF trial aims to enroll 500 patients in a pivotal study of the device, which is designed for patients with NHYA Class III and ambulatory Class IV symptomatic heart failure, the Israel-based […]
Judge pares claims in Bard IVC bellwether
A federal judge in Arizona yesterday pared some claims in the third bellwether case involving inferior vena cava filters made by Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard, as the trial entered its 11th day. It’s the fourth bellwether in the multi-district litigation over the IVC devices, which are designed to prevent blood clots from passing through […]
FDA clears Xtreem Pulse’s PureFlow counter pulsation system
Preventive healthcare tech company Xtreem Pulse said today it won FDA 510(k) clearance for its PureFlow system designed to treat refractory chronic stable angina. The New York-based company said that the system was designed on a concept called external counter-pulsation, and was originally designed to improve unhealthy cardiovascular function. The company also claims the system […]
LeMaitre Vascular ponies up $14m for Applied Medical’s clot management tech
LeMaitre Vascular (NSDQ:LMAT) this week ponied up $11 million in cash and another $3 million in post-closing payments for the vascular clot business at Applied Medical Resources Corp. The Burlington, Mass.-based company said the $14.2 million deal includes a one-year transition services provision that will see Applied Medical manufacture the devices for LeMaitre. The deal covers […]
Inari begins ClotTriever outcome study
Inari Medical said it has enrolled the first patient in the ClotTriever Outcomes Registry (“CLOUT”) using its ClotTriever thrombectomy system. The ClotTriever device is designed to remove blood clots from large vessels in the peripheral vasculature via access sites as small as 6 mm. CLOUT is a 500-patient prospective, multicenter, single-arm registry to evaluate real-world […]
Venus Medtech to acquire Keystone Heart
Chinese heart valve maker Venus Medtech said today it inked a deal to acquire cerebral embolic protection device maker Keystone Heart for an undisclosed amount. Tampa, Fla.-based Keystone Heart developed and produces TriGuard embolic protection devices, which are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce […]
Cardiovascular Systems touts first OUS use of orbital atherectomy system, eyes shift to revascularization
Cardiovascular Systems (NSDQ:CSII) today touted that its peripheral orbital atherectomy system was used in its first procedure outside the US as the company is reportedly looking to grow its business beyond a single product and towards supplying a full revascularization tool kit. The St. Paul, Minn.-based company said that its Stealth 360 peripheral orbital atherectomy system […]
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