Briefs
FDA Approves Corneal Implant for Presbyopia
The FDA approved Revision Optics’ Raindrop Near Vision Inlay, which is implanted in the cornea to improve near vision for presbyopia.
The approval marks the second corneal implantable device the agency has approved for near vision in patients who have not had cataract surgery. The device changes the shape of the cornea to improve vision.
The device resembles a contact lens and is made of hydrogel material. It is indicated for patients 41 to 65 years old who can’t focus clearly on near objects or small print. The device is inserted by a surgeon using a laser to create a flap in the cornea where the device is inserted.
The approval was supported by trials in 373 patients implanted with the device that showed two years after implantation, 92 percent of patients were able to see with 20/40 vision or better at near distances. The device is not recommended in patients who have severe dry eye.
HeartWare Extends Recall for Batteries
HeartWare is extending a recall to include batteries used in the HeartWare Ventricular Assist Device manufactured between May 2013 to July 2015. The recall extends to 18,631 units nationwide.
The devices help deliver blood from the heart to the body and are used in patients awaiting a heart transplant. The batteries may lose power prematurely due to faulty cells, which could cause serious adverse events. The FDA has identified the move as a Class I recall, the most serious type of recall. Use of the devices may cause serious injury or death.
The firm initiated an initial recall in January, requesting that healthcare providers quarantine the products and return the devices to the manufacturer. Read the recall notice here: www.fdanews.com/06-30-16-HeartWareRecall.pdf.
FDA Clears Cepheid’s Xpert Carba-R Assay
The FDA cleared for marketing Cepheid’s Xpert Carba-R Assay, which detects genetic markers associated with bacteria resistant to Carbapenem antibiotics.
Cepheid’s assay tests for the presence of five different genetic markers associated with carbapenemase. The test is intended as an aid in infection control, and should be used in conjunction with other clinical and laboratory tests since it does not detect all carbapenemase genes.
The marketing clearance was supported by data from two clinical studies that tested the diagnostic in 755 patients.
UK Warns on TRUEyou Glucose Strips
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certain lots of TRUEyou blood glucose tests strips may give incorrect readings that could lead to hyperglycemia.
MHRA said the issue relates to a small number of home-use blood glucose tests strips, and it is asking patients to return the tests to the manufacturer and discontinue use.
Medtronic to Acquire HeartWare for $1B
Medtronic will expand its heart failure portfolio with the acquisition of HeartWare International, the maker of circulatory support technologies for treating advanced heart failure.
HeartWare’s flagship product is the HVAD System, a miniature ventricular assist device.
Under the terms of the deal announced June 27, Medtronic will pay HeartWare shareholders $58 per share in all-cash deal worth roughly $1.1 billion. The acquisition is expected to close during the second quarter.