Medtronic (NYSE:MDT) announced Thursday that one of its new innovative medical devices — this time the world’s largest transcatheter aortic valve, part of its CoreValve line of heart valves — has been approved in Europe.
The valve is 31 mm in size but can be delivered with the same system that works with smaller, 26 mm and 29 mm CoreValve catheters. It now allows a minimally invasive — without open-heart surgery — option to patients with aortic stenosis who have large valves.
“We have seen positive clinical outcomes with the CoreValve System and are pleased to offer it to individuals who, until now, have been denied transcatheter aortic valve implantation due to their larger native valve size,” said professor Ulrich Schäfer from Asklepios Klinik St. Georg, Hamburg, in a news release.
The first CoreValve system was approved in Europe in spring of 2007 and has been implanted in more than 15,000 people in over 40 countries. The system is currently being tested in a large clinical trial in the U.S., although results aren’t available yet.
“We are very pleased with progress in the trial as all clinical sites are activated and many are actively enrolling and implanting patients,” said Kathleen Janasz, a Medtronic spokeswoman in an email.
Janasz added that about 100,000 Americans suffer from severe aortic stenosis and about 30 percent of these patients cannot have open-heart surgery to replace their valve because the risk is too high.
“For these individuals, minimally invasive transcatheter aortic valve implantation (TAVI) may be a promising new treatment option,” Janasz said.
A Deep-dive Into Specialty Pharma
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.
CoreValve is part of Medtronic’s CardioVascular business, which accounted for 18 percent of Medtronic’s overall revenue in fiscal year 2010. There is high expectation for CoreValve in the U.S., which the company expects to launch in 2014 after it is approved by the U.S. Food and Drug Administration.
CoreValve was described as one of two of the “most exciting new technologies in MedTech” by Medtronic CFO Gary Ellis in the company’s May 24 conference call with analysts.
Although Medtronic did not break out revenue of CoreValve in the May 24 call, Ellis did note that revenue of structural heart products increased 13 percent to $241 million in the fourth fiscal quarter spurred in part by “strong adoption of CoreValve in the international markets.”
