Regulators deal Wright Medical a double whammy
February 3, 2015 by Brad Perriello
Wright Medical said yesterday that it was hit with a double whammy from U.S. regulators, after the Federal Trade Commission asked for more details on its pending merger with Tornier and the FDA hit a plant where its Augment bone putty is made with a “Form 483” warning.
Memphis-based Wright said the FTC sent it a formal 2nd request Jan. 28, seeking more information on the Tornier deal, a $3.3 billion merger of equals announced last October. The FTC request extends the waiting period on the deal until 30 days after the request is met, unless extended by Tornier or Wright or closed early by the anti-trust watchdog. Read more
Medtronic wins FDA approval for Melody pulmonary valve
February 3, 2015 by Brad Perriello
Medtronic said today that it won pre-market approval from the FDA for its Melody transcatheter pulmonary valve, which is designed to delay the time between open heart surgeries in patients with a faulty connection from the heart to the lungs.
Fridley, Minn.-based Medtronic said the Melody TPV is designed for patients with a dysfunctional right ventricular outflow tract conduit caused by congenital heart disease. The PMA nod came after data from a trio of studies showed the valve’s effectiveness in delaying open heart procedures, according to a press release. Read more
FDA approves Cohera's TissuGlu surgical sealant
February 4, 2015 by Brad Perriello
The FDA today said it granted pre-market approval to Cohera Medical’s TissuGlu surgical sealant, making good on the approvable letter it sent to Cohera in early January.
TissuGlu is a polyurethane-based sealant designed for use in large-flap surgical procedures including abdominoplasty. It’s been on the market in Europe since September 2011 for the same indication. Read more