Corindus Vascular Robotics (OTC:CVRS) said today it won clearance from Japan’s Pharmaceutical and Medical Device Agency for its CorPath GRX robotic surgical device. The CorPath GRX vascular robotics platform is designed to assist cardiologists in performing percutaneous coronary interventions, including angioplasty and stent placement, Corindus said. “I look forward to offering CorPath GRX to my patients […]
Vascular
Keystone Heart launches new TriGuard embolic protection study
Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device. In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the […]
Report: Extra insights, but no clear-cut answers from TAVR embolic protection studies
Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report. Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did […]
Terumo’s MicroVention wins PMA for LVIS neuro stents
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for a line of neurovascular stents. Aliso Viejo, Calif.-based MicroVention said the federal safety watchdog approved its low-profile visualized intraluminal support devices for stent-assisted coil embolization of intracranial aneurysms. Previously approved under a humanitarian device exemption, the LVIS and LVIS Jr. […]
Preceptive Navigation wins $3m NIH grant for Vu-Path ultrasound nav device
Medtech company Perceptive Navigation said yesterday it won a $3 million Phase IIB Small Business Innovation Research grant from the National Heart, Lung and Blood Institute to support its Vu-Path ultrasound system. The Baltimore-based company’s Vu-path system is designed to aid in minimally-invasive, point-of-care procedures. The system is a miniaturized, forward-viewing ultrasound probe combined with […]
Cook Medical loses $1m IVC suit, plans appeal
UPDATED May 30 with verdict amount. Cook Medical said today that it plans to appeal the loss of a product liability lawsuit brought over its Celect vena cava filter. The ruling came from a jury in Houston, which ruled in favor of a plaintiff, though the Bloomington, Ind.-based company did not release any detailed information related to […]
EuroPCR Roundup: Biotronik touts two-year study comparing drug-eluting stents
Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent. Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of […]
Teleflex to acquire QT Vascular assets, takes option on Chocolate Heart DCB
QT Vascular said today it inked a deal to sell its non-drug coated coronary products to Teleflex (NYSE:TFX), including its Chocolate XD and Glider, with an option to purchase its Chocolate Heart drug-coated coronary balloon catheter which is currently under development. Singapore-based QT Vascular has not released any financial details of the deal, but said that it will […]
Avinger wins FDA nod for next-gen Pantheris
Avinger (NSDQ:AVGR) said today it won FDA 510(k) clearance for its next-gen Pantheris lumivascular atherectomy system, which it touts as the first image-guided atherectomy device designed for treating peripheral artery disease. Redwood City, Calif.-based Avinger said the newly cleared Pantheris device features a simpler, single-balloon system designed both for apposition and blood flow occlusion and improved pushability […]
FDA approves Abbott’s latest drug-eluting stent
Abbott (NYSE:ABT) said today that it won FDA approval for its Xience Sierra everolimus-eluting coronary stent. The company’s device features a thin profile, improved flexibility and longer lengths than previous stents. The device and delivery system were designed to help clinicians tackle complex cases, like those involving multiple or totally blocked vessels, according to Abbott. Get […]
Hancock Jaffe re-sets the range for $8m IPO
Medical device developer Hancock Jaffe Laboratories yesterday re-set the range on a pending initial public offering, which would fetch roughly $8 million at the midpoint. Irvine, Calif.-based Hancock Jaffe makes bioprosthetic implants designed to treat chronic deep vein insufficiency, heart valve conditions and coronary artery bypass graft. Last December the company said it planned to float nearly 1.9 million […]