Abbott recently earned FDA approval for its latest transcatheter aortic valve implantation (TAVI) system, which is named Navitor. Abbott will have to fight for its place the U.S. TAVI device space, as the systems made by Edwards and Medtronic have a steadfast command of the market share.
Read about executive hires across healthcare and life sciences.
Edwards Lifesciences introduced TAVR to the U.S. back in November 2011 when FDA approved its Sapien heart valve for patients with aortic stenosis who were too sick to undergo open heart surgery. This episode of Pivot features Larry Wood, corporate vice president for TAVR with Edwards, who reflects on the journey.
Edwards Lifesciences is paying up to $690 million to a buy an Israeli company that makes transcatheter mitral valve and tricuspid repair devices. Last year it bought a mitral valve replacement company for about $400 million.
Johnson & Johnson's chief executive is on the hunt for a structural heart company to add to its medical devices business. Does it make sense to buy a company that is the big name in the market?
Heart failure device startup CardioKinetix should have ample funding to wrap up a pivotal clinical trial that’ll allow it to receive pre-market approval from the FDA: It just raised $50 million in financing, led by Edwards Lifesciences Corp. – which also scooped up exclusive rights to acquire CardioKinetix based on future regulatory milestones. Menlo Park-based CardioKinetix has […]
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.
by Chris White and Diane Biagianti Partners for Healthy Dialogues partner Christopher White (general counsel, AdvaMed) recently sat down with Diane Biagianti, vice president, chief responsibility officer, Edwards Lifesciences, to talk about the importance of collaboration between physicians and medical technology companies, and implementing the Physician Payments Sunshine Act. How do patients benefit from interactions […]
Edwards Lifesciences (EW) joined BioMedPartners to add $3 million to Middle Peak Medical‘s already oversubscribed Series A round. The funding will go toward commercializing technology to treat mitral valve disease. Lead investors Wellington Partners and Seventure Partners, added to their investment from the first close, which also included High-Tech Gruenderfonds, according to a press release. In […]
As global medical device companies try to take on more of the care continuum, they might be able to turn to that little Starbucks coffee shop just around the corner. It might seem sacrilege to compare the intricacies of neuromodulation with a perfectly brewed, expertly crafted cup of joe, but here I find myself. Why? […]
The U.S. Supreme Court has decided to reject a Medtronic (MDT) appeal and leave the Edwards Lifesciences (EW) valve patent intact, which stands to lose Medtronic as much as $200 million, Bloomberg reports. The medical device company has received a big blow in its battle with Edwards Lifesciences, but the court may hear its arguments against a patient-plaintiff. The […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Edwards LifeSciences Corp. reported a total revenue of $517 million for Q2, with 7.3 percent increased net sales, “driven by strong sales of transcatheter and surgical heart valves in both the U.S. and Europe,” CEO Michael Mussalem said. Combined, the two provided 16 percent of sales in the U.S., helped by the SAPIEN launch in the U.S.. […]
Medtronic’s (NYSE:MDT) legal battle with Edwards Lifesciences over patent infringement and its transcatheter aortic valve products has been going on for years and last week a federal appeals court affirmed a lower court’s ruling in Edwards’ favor allowing that Medtronic had, in fact, willfully infringed on a single Edwards’ patent. It asked Medtronic to pay damages, […]
Losing the Ryder Cup this year to the Europeans was every bit unexpected. Almost as unexpected as Edwards Lifesciences suddenly pre-announcing late Monday that it would miss its 3rd quarter revenue forecasts largely because of poor sales growth for U.S. transcatheter aortic valve replacement procedures. Third quarter U.S. TAVI sales of $55 million were off […]
Many believe that transcatheter aortic valve implantation is one of the most exciting and lucrative new technologies to hit the market providing an option for patients to sick to undergo open heart surgery. Edwards Lifesciences, the Irvine, California, firm has the lead in the U.S. market with its Sapien transcatheter aortic valve replacement system. Medtronic, […]
Medical device companies are battling low utilization, economic uncertainty in Europe and headwinds in the U.S. in the form of the medical device tax and changes wrought by healthcare reform. In the midst of it all, Edwards Lifesciences (NYSE:EW) showed that the launch of its highly anticipated Sapien transcatheter valve implantation system could not have […]
