Category: Heart Valves
Heart Valves
Medtronic Inc. launches a 1,000-patient study of its CoreValve aortic stenosis therapy, designed as a minimally invasive method of replacing faulty heart valves.
By Brandon Glenn
Medtronic Inc. (NYSE:MDT) launched what’s expected to be a 1,000-patient study of a catheter-based system it hopes will become a less-invasive — and highly lucrative — alternative to open-heart surgery for valve replacement.
Medtronic’s CoreValve system allows a replacement heart valve to be placed in a patient’s body via a catheter inserted in the femoral artery, near the groin. A catheter is a thin, flexible tube that can be inserted into a body cavity to open a passageway or to allow fluids to pass through.
The U.S. Attorney for Massachusetts issues a "civil investigative demand" for documents on Medtronics' CoreValve subsidiary and its relationship to the Lahey Clinic in a false claims investigation.
It's shaping up to be a tough day for Medtronic Inc. (NYSE:MDT), as news of a federal false claims investigation follows questions from the Food & Drug Administration about a study of one of its deep-brain stimulation devices.
The Fridley, Minn.-based medical devices monolith revealed in a March 10 securities filing that the U.S. Attorney for Massachusetts issued a "civil investigative demand" Feb. 22 for documents in a false claims probe into the relationship of its CoreValve subsidiary with the Burlington, Mass.-based Lahey Clinic, "specifically relating to cardiologists at the clinic, CoreValve Inc. ... and the Lahey Clinic, and certain employees of both [Medtronic] and the clinic, among other topics."
Cardiac device will know be able to sell its Trifecta aortic valve replacement in the European union.
By Brandon Glenn
LITTLE CANADA, Minnesota — St. Jude Medical Inc. (NYSE:STJ) won European approval to begin selling its Trifecta valve, which is designed to replace a patient’s damaged aortic valve.
Minneapolis, Minn.-based heart valve repair products maker ATS Medical Inc. reports a 13 percent revenue bump during 2009.
ATS Medical Inc. (NSDQ:ATSI) reported sales of $18.7 million during the fourth quarter, an increase of 4 percent when compared to the $18 million the company reported during the same period in 2008.
The Minneapolis, Minn.-based heart valve repair products company managed to trim its net loss to $3.4 million for the three months ended Dec. 31, 2009, a 62 percent decrease from the $8.5 million the company lost during the same period last year.
For the year, ATS managed to narrow its net losses by 68 percent, reporting a loss of just over $6 million on $75 million in sales, compared to a $19 million loss on $66 million in sales during 2008.
The Food & Drug Administration granted a humanitarian device exemption to Medtronic Inc.'s Melody transcatheter pulmonary valve repair system.
By Thomas Lee
FRIDLEY, Minnesota- The Food & Drug Administration approved a new type of arterial valve designed for patients, mostly young children, suffering from congenital heart disease made by Medtronic Inc. (NYSE:MDT).
Cardiology device maker ATS Medical Inc. announces the completion of the first commercial implants of its recently cleared sutureless aortic valve.
By Brandon Glenn
MINNEAPOLIS, Minnesota — Cardiology device maker ATS Medical Inc. (NSDQ:ATSI) announced the completion of the first commercial implants of its recently cleared sutureless aortic valve.
Recent board addition Robrecht Michiels brings in the bucks for Winchester, Mass.-based transcatheter heart valve developer CardiAQ Valve Technologies.
Barely four months after being named to the board of CardiAQ Valve Technologies, Robrecht "Rob" Michiels led a group of angel investors in a $6.5 million boon for the Winchester, Mass.-based start-up.
