Medtronic Receives FDA Approval for its Replacement Heart Valve and Acquires Invatec

The U.S.Food and Drug Admnistration (FDA) has approved a transcatheter heart valve made by Medtronic Inc. that can be implanted through a tube in a leg vein and guided up to the heart. The endorsement is the agency’s first of a percutaneous transcatheter heart valve, the company claimed.

The Melody Transcatheter Pulmonary Valve was approved under the FDA’s Humanitarian Device Exemption program, which supports the development of medical devices that treat diseases or conditions afflicting less than 4,000 people annually. The valve was designed for use in both children and adults with a pulmonary valve defect.

Clinical studies of 99 U.S. patients and 68 European patients showed that the device improved heart function and clinical symptoms in most of the people who received it, a news release stated. However, the valve showed limited durability when compared with existing treatments such as bare metal stents.

“The Melody valve gives patients with congenital heart disease a new, non-surgical approach to managing their disease,” said William E. Hellenbrand, M.D., a pediatric cardiologist at New York-Presbyterian Morgan Stanley Children’s Hospital and Columbia University Medical Center in New York, N.Y. “The Melody valve is a significant technological breakthrough and offers a reprieve for many patients with congenital heart disease, many of whom are young and will require several heart surgeries over their lifetimes.”

As a condition of the FDA’s approval, Medtronic will conduct two post-approval studies to assess long-term risks and benefits, and evaluate the kinds of skills doctors need to perform the procedure. One study will follow 150 patients from the original clinial trial for five years, while the other will monitor 100 new patients for five years.

“The FDA’s approval of Melody allows patients to undergo a much less invasive procedure to treat their heart condition,”Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health said in a news release. “Congenital heart defects represent the number one birth defect worldwide and this approval represents a new, first-of-a-kind treatment option for some of those patients.”

The FDA’s approval of Medtronic’s heart valve came on the same day the company announced the acquisition of Invatec and two affiliated companies for $350 million. Invatec manufactures devices that treat cardiovascular disease.

The agreement calls for medical device giant Medtronic to make additional payments of up to $150 million for Invatec’s achievement of specific milestones.

Medtronic also has agreed to acquire Invatec affiliated firms Fogazzi, which provides polymer technology to Invatec; and Krauth Cardiovascular, which distributes Invatec products in Germany.

Invatec’s core competencies include polymer processing, metallurgy, surface treatments and drug coatings and has full in-house capabilities to design, develop, manufacture and assemble devices.

Its products include stents and angioplasty balloons. According to Medtronic, Invatec has brought four drug-eluting balloons to market, covering the coronaries and lower-extremity vessels and is a pioneer in the development and commercialization of lesion-specific solutions, including therapies for below-the-knee and carotid artery disease.

“Medtronic’s acquisition of Invatec will accelerate the growth of our CardioVascular business, adding important new products for the coronary and peripheral vascular markets,” said Scott Ward, senior vice president at Medtronic and president of the CardioVascular business.

Andrea Venturelli, co-founder, chief executive and technical officer of Switzerland-headquartered Invatec, said: “Invatec brings to Medtronic an established international business with a European center of technology development and manufacturing, as well as a strong history of delivering products and high-value solutions to the interventional market.”

Invatec was founded in 1996 by Andrea Venturelli and Stefan Widensohler, and employs approximately 900 people, predominantly in Brescia, Italy, and Frauenfeld, Switzerland.