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 […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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 (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 […]
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 […]
This eBook, in collaboration with Care Logistics, details how hospitals and health systems can facilitate more effective decision-making by operationalizing elevated awareness.
UPDATE: In response to St. Jude Medical’s request for retraction, the editor-in-chief of the Heart Rhythm Journal said that he has offered the chance for St. Jude to write a letter to the editor but is not going to retract the article. “I’ve talked with the leadership of the Heart Rhythm Society, I’ve talked with […]
St. Jude Medical (NYSE:STJ) announced Wednesday that it will stop selling two leads because the wires inside the leads can poke through their silicone insulation. The Minnesota device maker said that it had informed physicians that the problem affected several models of the QuickSite and QuickFlex Left Ventricle leads used in cardiac resynchronization therapy pacemakers […]
A team of researchers has found that St. Jude Medical’s defective Riata and Riata ST leads have directly caused 22 deaths or 31 percent of all deaths involving the lead family. Most surprisingly, the deaths were caused by electrical malfunction at high voltages — and not because of lead wires coming out of their insulation. […]
St. Jude Medical (NYSE:STJ) announced Friday that the U.S. Food and Drug Administration has cleared the next iteration of its Fractional Flow Reserve technology used to treat clogged arteries. The clearance allows the Minnesota medical device maker to market a new generation of PressureWire Aeris and PressureWire Certus guidewires, which have an “agile tip” whose […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
SCROLL BELOW FOR UPDATE Continuing its push to make fractional flow reserve technology the standard in treating clogged arteries through percutaneous coronary intervention (PCI), St. Jude Medical (NYSE:STJ) announced Wednesday that it is initiating a study to review the cost effectiveness of this technology in Asia. One analyst, however, is not convinced about […]
It was supposed to be a closed meeting attended by doctors who had a large amount of experience dealing with patients with St. Jude Medical’s Riata leads, a defibrillator lead that recently garnered an FDA Class I advisory (recall) status due to it’s high failure rate. Only 55 doctors and a few industry personnel were […]
As the market for cardiac rhythm management devices slows in the U.S., medical device makers have been rapidly looking at other avenues for growth. For St. Jude Medical (NYSE:STJ), one such growth opportunity comes from its highly vaunted fractional flow reserve technology, which is used in conjunction with percutaneous coronary intervention to treat patients with clogged […]
Despite its troubles related to the Riata and the Riata ST lead recalls, St. Jude Medical CEO Daniel Starks told analysts Wednesday that the company will gain a 1 percentage point market share in the global cardiac rhythm market in 2012. The company’s CRM segment includes implantable cardioverter defibrillator and pacemaker products. In discussing the […]
The Class I recall of the two Riata defibrillator leads from St. Jude Medical (NYSE:STJ) highlighted the issue of lead abrasion and insulation, but both those leads don’t have St. Jude Medical’s Optim technology. When lead abrasion occurs, it can cause the electrical conductors inside leads to come out of the insulation. Optim is a […]