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$MDT said the U.S. Food and Drug Administration cleared its TrailBlazer angled support catheter for use in the peripheral vascular system. Support catheters such as the Trailblazer are often used in endovascular procedures treating complex peripheral artery disease. FDA clearance was received on September 23, 2016.
$MDT received FDA clearance of the Riptide Aspiration System, adding a valuable tool to the Acute Ischemic Stroke (AIS) product portfolio. This is designed to retrieve thrombus (or blood clot) through the Arc Catheter and restore blood flow in patients experiencing blockage of an artery in the brain, known as an ischemic stroke.
The FDA has approved an innovative clinician programmer for the SynchroMed-II Intrathecal Drug Delivery system developed by medical technology company $MDT, for chronic pain and spasticity. SynchroMed-II, an implantable pump, delivers medication directly to the fluid around the spinal cord. It is an app that facilitates simple, guided workflows.
$ZBH appointed Bryan Hanson as President and CEO and a member of the BoD, effective Dec. 19, 2017. Daniel Florin, who has served as Interim CEO since July 11, 2017, will continue in his role as SVP and CFO. Most recently, Hanson served as a $MDT's Executive Committee member and as EVP and President of Medtronic's Minimally Invasive Therapies Group.
$MDT has named Bob White, previously SVP and President of APAC Region, as EVP and President of Minimally Invasive Therapies Group. The company also announced Chris Lee, SVP and President of Greater China Region, will assume the position of APAC Region President. These leadership changes are effective immediately.
In Oct., Animas announced to cease the manufacture and sale of its insulin pumps and partnered with $MDT to offer its customers the opportunity to transfer to a new device.With $JNJ exiting the insulin pump market in the US and Canada, $MDT now has access to the 90,000 patients who use Animas insulin pumps.
$MDT got US FDA approval for its MiniMed 670G hybrid closed-loop system and rolled the device out in a Priority Access program. It began shipping systems to patients in June. The company now expects growth to significantly improve in 3Q18 as it has finished shipping pumps for the program.
Given the recent events of hurricanes and wildfires, $MDT managed to restrict its revenue decline to just 4% for 2Q18. The medical-device maker saw its profit grow 81% on a GAAP basis. On adjusted basis, earnings fell 4% to $1.07 per share.
Preliminary 2Q18 Results: $MDT worldwide revenue declined 4% to approx. $7.05Bil, with the decline driven by the company's divestiture of its Patient Care, Deep Vein Thrombosis and Nutritional Insufficiency businesses to $CAH. The company expects the impact of Hurricane Maria to be approx. $0.03 to non-GAAP EPS for 2Q18.
$MDT said its Medtronic Care Management Services (MCMS) business and American Well entered into a strategic partnership. Under the agreement, the businesses will work together to enable patient access to American Well's telemedicine services on MCMS' video-enabled platforms, and to allow bi-directional data flow between the two parties.
Animas Corp., a $JNJ Diabetes Care Companies, plans to discontinue the manufacturing and sale of Animas Vibe and OneTouch Ping insulin pumps, close operations and exit the insulin pump business. Animas has selected $MDT as its partner-of-choice to facilitate a seamless transition for patients, caregivers and healthcare providers.
Chairman of $HRC Board Rolf Classon will not stand for re-election to the BoD when his current term expires on March 6, 2018. The Board plans to appoint current independent director William Dempsey to this role if he is re-elected by shareholders. The company also elected Gary Ellis, retired CFO and SVP of $MDT, to its BoD, effective Oct 5, 2017.
$MDT announced FDA approval and U.S. launch of the Intellis platform for the management of certain types of chronic intractable pain. The Intellis platform was designed to overcome limitations with current spinal cord stimulation (SCS) systems, such as battery performance, and can power the Evolve workflow.
$MDT voluntarily recalls specific lots of infusion sets used with all models of Medtronic insulin pumps due to a certain discontinued component. The recall comes after reports from patients that a component, the vent membrane, may be susceptible to being blocked by fluid during priming and fill-tubing, which can lead to over-delivery of insulin.
$MDT's IN.PACT Admiral Drug-Coated Balloon received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of peripheral artery disease in the upper leg. Before $MDT can begin commercialization, it must partner with Japanese MHLW to gain reimbursement to ensure broader access to this therapy.
$MDT launched a long-term clinical study of its INFUSE Bone Graft for use during Posterolateral Fusion (PLF) and Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures. The first patient has been enrolled in the PLF study. The 10-year program is looking to enroll 550-700 individuals between the pilot and pivotal studies of both procedures.