Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter aortic heart valve replacement designed for treating severe aortic stensosis. The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based […]
Medtronic
Medtronic plans $2B debt flotation
Medtronic (NYSE:MDT) today announced a series of upcoming offerings, looking to bring in approximately $2 billion. The Fridley, Minn.-based company announced 2 offerings to be held through its subsidiary Medtronic Global Holdings, or Medtronic Luxco, looking to bring in $1 billion in 1.7% senior notes due 2019 and $850 million in 3.35% senior notes due 2027. Medtronic […]
ACC 2017 Roundup: Abbott touts reduced HF rehospitalizations in MitraClip study
The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as news comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19. Abbott touts reduced HF rehospitalizations in MitraClip study Abbott (NYSE:ABT) released 1-year outcomes from the largest study to-date of real-world experiences […]
Medtronic recalls StrataMR valves & shunts
Medtronic (NYSE:MDT) this month initiated a voluntary recall of all unused StrataMR adjustable valves and shunts over issues with the flow resistance in the valve which may result in under drainage of cerebrospinal fluid. The Fridley, Minn.-based company said such a condition can occur in the units when the valve mechanism is adjusted to a position […]
Medtronic’s HeartWare launches new HVAD controller, recalls older models
The HeartWare subsidiary Medtronic (NYSE:MDT) acquired for $1 billion last year is launching a new controller for its HVAD left ventricular assist devices and recalling older versions of the device. Issues with the implantable heart pump’s controller date back to at least April 2010, when HeartWare said a July 2009 redesign aimed at waterproofing the controllers inadvertently made them […]
Report: Cardinal Health among bidders for Medtronic’s $5B medical supplies biz
Cardinal Health (NYSE:CAH) is one of several companies looking to pick up Medtronic’s medical supplies business, estimated to be worth $5 billion, Bloomberg News reported this week. The Dublin, Ohio.-based company is at the head of the pack of companies looking to buy the supplies business, according to Bloomberg, citing sources with knowledge of the deal. […]
Medtronic’s SynchroMed woes delay United Therapeutic’s Remodulin
Shares in United Therapeutics (NSDQ:UTHR) fell -3% yesterday on a possible delay for the release of a programmable infusion pump for its drug, Remodulin. Yesterday, the FDA updated Medtronic‘s (NYSE:MDT) Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps. RBC Capital reportedly said the recall puts United Therapeutics at heightened risk for […]
FDA announces updates to Medtronic’s Class I recall for SynchroMed drug pumps
The FDA today updated Medtronic’s Class I recall for the company’s SynchroMed II and SynchroMed EL implantable drug pumps, which were designed to locally treat primary or metastatic cancer, chronic pain, and severe spasticity. The pumps were recalled in 2013 because they unintentionally delivered drugs during the priming bolus procedure and patients were at risk for […]
Medtronic wins extended FDA indication for bone cement
Medtronic (NYSE:MDT) said today that it won 510(k) clearance for its Kyphon Xpede bone cement for the fixation of pathological fractures of the sacral vertebral body using sacral vertebroplasty or sacroplasty. The regulatory win expands the product’s original indications beyond treating vertebral fractures due to osteoporosis, cancer or benign lesion. Nearly 54 million Americans suffer […]
Medtronic wins expanded FDA indication for Melody TPV
Medtronic (NYSE:MDT) said today it won extended FDA approval for its Melody transcatheter pulmonary valve, now indicated for implantation in patients whose surgical bioprosthetic pulmonary heart valves have failed. The Fridley, Minn.-based company touted the Melody TPV as the 1st transcatehter pulmonary valve to win such an indication from the federal watchdog. “Unlike other transcatheter […]
Medtronic wins FDA nod for next-gen Linq ICM
Medtronic (NYSE:MDT) said today it won FDA 510(k) clearance for its next-gen Reveal Linq insertable cardiac monitor with TruRhythm Detection. The Linq ICM with TruRhythm Detection offers exclusive algorithms which the Fridley, Minn.-based company said resulted in a 95% reduction in false bradycardia episodes and a 47% reduction in false pause episodes compared with the […]