UPDATE: An earlier version of the story incorrectly reported that the patient with the Durata lead that had externalized conductors died. The FDA Maude adverse event database does show that patients implanted with Durata leads have died but those were not connected to device problems. Externalized conductors is the failure that led to the recall […]
St. Jude Medical (NYSE:STJ) has agreed to pay $3.65 million to settle a Department of Justice inquiry into the company’s alleged practice of overstating the price of its replacement defibrillators and pacemakers. The Justice Department announced Thursday that the settlement resolves allegations related to the company’s warranty discount program. St. Jude marketed a discount […]
Solera Health is working to streamline employer contracting with health tech.
When it comes to commercialization efforts of renal denervation therapy, St. Jude Medical (NYSE:STJ) is behind Medtronic (NYSE:MDT). But St. Jude Medical is hoping that slow and steady may still win the race in the quest to use this novel treatment in patients whose high blood pressure is not controlled by medication. The device maker announced […]
Life science current events this week include J&J and MDT's contrasting acquisition strategies, the transcatheter valve replacement market and cardiovascular disease medical device companies.
The Heart Rhythm Society’s annual meeting kicked off today in Boston, and reportedly the session on the faulty St. Jude Medical (NYSE:STJ) ICD leads was packed. The problem with St. Jude Medical’s defective Riata and Riata ST leads is well known — lead wires have a potential to poke through insulation and hurt patients. Others […]
The U.S. Food and Drug Administration has approved a new, smaller implantable cardioverter defibrillator made by St. Jude Medical (NYSE:STJ), the medical device maker announced Wednesday. The announcement comes less than a month after the device maker said that European regulators had given the nod to the same device — the Ellipse ICD. The Ellipse […]
Richard Fu details the company's approach to nutrition therapy and strategy for patients using GLP-1s.
St. Jude Medical (NYSE:STJ) announced Tuesday that the U.S. Food and Drug Administration has approved the Assura line of implantable cardioverter defibrillators and cardiac resynchronization therapy devices. The new devices reduce the potential for inappropriate shocking because the device has advanced algorithms that can discern between a real event requiring a life-saving therapy and one […]
St. Jude Medical and Abbott announced Monday that they are expanding a marketing relationship, and striking a new distribution partnership such that they can present a bundled package of cardiovascular products to hospital customers. A medical device marketing expert said that because the two companies have complementary products the partnership brings a potential competitive advantage. […]
St. Jude Medical (NYSE:STJ), which reported better-than-expected results for the first quarter, is expecting an improvement in its U.S. implanted cardioverter defibrillator business. “On the cardiac rhythm business, we have a lot of good, positive early indicators,” said CEO Daniel Starks, in a conference call on Wednesday. “We measure the total number of active accounts […]
By several estimations, the response from St. Jude Medical (NYSE: STJ) to a prominent cardiologist critical of the company’s faulty Riata leads has been unprecedented. St. Jude Medical launched an offensive against Dr. Robert Hauser, a senior consulting cardiologist at the Minneapolis Heart Institute, calling his study critical of the company’s recalled leads as inaccurate […]
How Apella leverages technology to increase OR efficiency.
St. Jude Medical (NYSE:STJ) announced Tuesday that it has won Japanese regulatory approval to market a new smaller heart valve in Japan. The new Trifecta aortic stented, pericardial tissue valve has been implanted in procedures at Osaka University Hospital and Saitama Medical University International Medical Center, according to the company. To ensure the structural integrity of […]
St. Jude Medical (NYSE:STJ) announced Monday that it has won regulatory approval from the European Union to market a smaller implantable cardioverter defibrillator. The Ellipse is the industry’s smallest high-voltage ICD, said a company news release that described the product as the result of physician input. The device design was arrived at through focus groups of […]
The St. Jude-MDT smackdown on the Riata lead performance continues. (For some background, here’s my original post). After seeking a retraction of Robert Hauser, MD’s paper that identified 22 deaths from the Riata lead in the Heart Rhythm Journal, St. Jude’s attempt to secure the retraction of the peer-reviewed paper that was released electronically […]
When you take money from everyone, is it no longer a conflict of interest? I only raise the question after reading the latest in the ongoing dust-up over implanted defibrillators, where the latest company on the hot seat for selling flawed devices (St. Jude Medical) has accused the scientist who brought the situation to light–Dr. […]
I have always found the weather and the people to be a little cold in Minnesota. Reporters like a little action and the Midwestern penchant for not creating any ripples is frankly a little disappointing. This morning was unlike any other I have experienced in covering medical devices.