It's been a long road for St. Jude Medical with its stroke prevention device, but the company is celebrating a milestone after an FDA panel recommended the product for approval.
Otsuka has given renal denervation to treat hypertension another vote of confidence. It's signed a distribution deal for certain Asian companies with startup ReCor Medical, as well as making an additional investment in the company.
St. Jude Medical presented data on its leadless pacemaker and cited two other presentations given at this year's Heart Rhythm Society gathering that demonstrated the Nanostim device can be successfully retrieved from patients without serious adverse complications.
Abbott Laboratories is seeking a new path to growth--and it's betting big that med tech is it. The company is taking on two of the largest M&A transactions in history at the same time: the more than $5.8 billion purchase of diagnostics player Alere that it announced at the start of February and the more than $25 billion buy of cardiovascular device player St. Jude Medical that was disclosed in late April.
The medical device industry has been working on miniaturizing pacemakers so they can be minimally invasively inserted and cause fewer difficulties for patients. Up next likely are closed-loop systems: pacemakers that record patient data, transmit that data externally and enable adjustment based on that data by physicians or even, eventually, on their own as guided by advanced algorithms.
Venus Medtech aims to have the first transcatheter aortic valve implantation system cleared by the China Food and Drug Administration (CFDA). It also has a transcatheter pulmonic valve that is finishing clinical trials, which would also be a first for the CFDA.
St. Jude Medical has launched its Axium Neurostimulator System for dorsal root ganglion stimulation to treat patients with chronic pain.
Medtronic has won the first U.S. approval for a leadless pacemaker from the FDA. The inch-long device is the smallest available and is implanted directly into the heart's right ventricle chamber. Traditional pacemakers require wired leads to connect the device to the heart.
St. Jude Medical touted an independent study from a New York healthcare system during the annual meeting of the American College of Cardiology, which showed patients who were implanted with the company's CardioMEMS patient monitoring cardiology implant experienced a plethora of benefits.
Medicare administrative contractor Novitas said it would not cover St. Jude Medical's implantable CardioMEMS heart failure monitor, dealing the device another reimbursement setback. Last, year First Coast Medicare denied coverage of the device in Florida, Puerto Rico and the Virgin Islands.