Anti-trust regulators in China today granted conditional approval to the $25 billion tie-up of Abbott (NYSE:ABT) and St. Jude Medical (NYSE:STJ). China’s Ministry of Commerce said the approval is conditioned on the sale of St. Jude’s small vessel closure device business; the companies would have 20 days from the close of their deal to execute the sale of […]
Vascular
Medtronic’s Ev3 wins 2nd appeal in ex-rep’s whistleblower lawsuit
A federal appeals court last week dismissed a whistleblower lawsuit filed by a former sales rep for Medtronic (NYSE:MDT) subsidiary Ev3, ruling that the allegations weren’t strong enough to sustain a False Claims Act suit. Whistleblower Jeffrey D’Agostino in October 2010 filed a qui tam lawsuit alleging that Ev3 violated the FCA by promoting its Onyx hydrogel […]
Endologix puts hold on AFX shipments over manufacturing issues
Endologix (NSDQ:ELGX) said today it is temporarily holding shipments of its AFX Endovascular abdominal aortic aneurysm system as it completes an investigation of manufacturing issues with the devices. The AFX system is designed to provide anatomical fixation to treat a wide range of AAA anatomies, according to the company. The hold came only weeks after Endologix […]
Stryker’s Concentric Medical wins Class II FDA label for Trevo clot retrieval devices
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II. Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA. The federal watchdog reviewed the order, and said that on September 2 it issued an order […]
FDA expands clearance for Avinger’s Lightbox L250 vascular imaging console
Avinger (NSDQ:AVGR) said today that it won 510(k) clearance from the FDA for its Lightbox L250 imaging console. The software is designed to improve visualization inside vessels before, during and after Pantheris Lumivascular atherectomy procedures in patients with peripheral artery disease. “The ability to obtain an accurate and real-time measurement from inside a diseased vessel is […]
QT Vascular subsidiary TriReme lands GPO deal with HealthTrust
QT Vascular said yesterday that its TriReme Medical subsidiary inked a group purchase agreement with Healthtrust Purchasing Group. Through the newly signed deal, Healthtrust will gain access to TriReme’s portfolio of specialty angioplasty balloons designed to treat blood vessel blockage due to arterial disease, QT Vascular said. Nashville, Tenn.-based HealthTrust serves more than 1,400 acute care […]
Getinge’s Maquet files suit against Saphena Medical
Getinge‘s (PINK:GETI B) medical subsidiary Maquet Cardiovascular said it filed a lawsuit this week against Saphena Medical and former employee Dr. Albert Chin, asserting that both parties infringed upon patents related to its VasoView endoscopic vein harvesting products. The suit, filed in the US District Court for the Northern District of California, asserts Dr. Chin took […]
China’s Microport puts $15m into Lombard Medical
Lombard Medical Technologies (NSDQ:EVAR) said today that China’s MicroPort Orthopedics invested $15 million as part of a partnership deal between the 2 companies. Through the partnership, Lombard will seek to accelerate commercialization of its Aorfix and Altura stent grafts for treating abdominal aortic aneurysms. Microport will gain exclusive marketing rights for both products in China and Brazil, as […]
QT Vascular wins full FDA IDE approval for Chocolate Touch DCB pivotal trial
QT Vascular said today it won full FDA investigational device exemption approval to initiate a trial of its Chocolate Touch drug-coated balloon designed to treat vascular disease. The Singapore-based company said it looks to enroll 585 patients at up to 50 US centers for the prospective, randomized trial, which aims to explore the use of the device […]
J&J’s Codman Neuro picks up Pulsar Vascular
Johnson & Johnson‘s (NYSE:JNJ) Codman Neuro said last week it picked up Pulsar Vascular, which produces the PulseRider device for treating brain aneurysms, for an undisclosed amount. The PulseRider is designed to shore up the blood vessels around wide-necked aneurysms at or near a bifurcation of the basilar tip or carotid terminus and facilitate the implantation of […]
Silk Road touts low stroke rate in 2 studies of Enroute TCAR system
Silk Road Medical yesterday released data from 2 studies of its Enroute transcarotid neuroprotection and stent system, including 1-year data from a pivotal trial of the device and an interim analysis of a post-approval study of the Enroute. Data from the studies was presented last month at the 44th annual Veith Symposium in New York. The Sunnyvale, Calif.-based […]