January 24, 2010
Medtronic to Acquire Invatec; Invatec Marks Product Milestones
January 25, 2010—Medtronic, Inc. (Minneapolis, MN) announced that it has signed a definitive agreement to acquire Invatec (Roncadelle, Italy), a developer of medical technologies for the interventional treatment of cardiovascular disease, and two affiliated companies: Fogazzi (Brescia, Italy), which provides polymer technology to Invatec, and Krauth Cardio-Vascular GmbH (Hamburg, Germany), which distributes Invatec products in Germany. The agreement calls for Medtronic to make an initial payment of $350 million to Invatec and additional payments of up to $150 million for Invatec's achievement of specific milestones.
According to Medtronic, Invatec's product line of stents, angioplasty balloons, and accessory products complement therapies and products in Medtronic's cardiovascular business. The acquisition of Invatec adds a peripheral franchise and pipeline to Medtronic and enhances its coronary product offering. Invatec has brought four drug-eluting balloons to market (outside the United States), covering the coronaries and lower extremity vessels. It develops lesion-specific solutions, including therapies for below-the-knee and carotid artery disease, Medtronic stated.
On January 19, Invatec announced that it received 510(k) clearance from the US Food and Drug Administration to market the Reef HP percutaneous transluminal angioplasty (PTA) balloon catheter for use in peripheral high-pressure dilatation procedures. The company stated that the lesion-specific design of the balloon material is particularly useful in patients with a range of peripheral lesions, such as dialysis patients, whose arteriovenous shunts often create fibrous and hard-to-dilate lesions. The Reef HP balloon is made from Invatec's Flexitec XF material, with a working pressure range of up to 22 atm, a low compliant balloon, and low-profile design. In the United States, the balloon is available in diameters of 4 to 8 mm and lengths of 20 to 80 mm, Invatec advised.
"We often encounter calcified and resistant lesions in peripheral vessels and in hemodialysis access interventions," commented Robert L. Vogelzang, MD. "Invatec's addition of a high-pressure PTA balloon will aid in the successful treatment of these challenging lesions."
On January 27, Invatec announced the European launch of the Maris Plus self-expanding peripheral stent system in new 6-, 7-, and 8-mm diameters, appropriate for interventions involving the superficial femoral arteries. The 9-, 10-, and 12-mm diameters of the stent are already marketed for the iliac arteries. At the stent ends, the device's cell design allows interventionists to place several stents in series without stiffening the artery in the overlap region. The stent geometry creates an overlap region that allows two stents to act like one in the femoral artery and provides flexibility, fracture resistance, and tailored deployment, the company stated.
On January 29, Invatec announced that the first clinical results for the use of the In.Pact Amphirion paclitaxel-eluting balloon for complex critical limb ischemia (CLI) in below-the-knee vessels were presented at the LINC 2010: Leipzig Interventional Course meeting in Leipzig, Germany. Investigator Andrej Schmidt, MD, reported that preliminary results indicate a dramatic reduction in the restenosis rate with application of the device.
Dr. Schmidt commented, "In our experience, 69% of CLI patients with long lesions show restenosis after 3 months. The In.Pact Amphirion was able to bring this number down to 31%. Considering the mean lesion lengths of 17 cm and 58% rate of total occlusions before intervention, these results have the potential to change the way we treat complex CLI."
Professor Dierk Scheinert, MD, principal investigator of the In.Pact Amphirion registry, added, "It took us several years to develop adequate techniques to successfully reopen below-the-knee arteries, but we had no means of preventing restenosis for longer arterial segments. Drug-eluting stents are only feasible in short lesions. The drug-eluting balloon is the first method that brings down restenosis rates in those complex CLI cases. An interesting observation is also the nature of the restenosis, if it appears after treatment with the drug-eluting balloon, we see focal segments, not renarrowing along the total artery. This makes reintervention less complex."
Invatec plans to proceed with its clinical trial program to provide further definitive proof that drug-eluting balloons can benefit patients with arterial disease in the coronaries, in hemodialysis shunts, and throughout the entire leg. The company has initiated several clinical trials to assess its In.Pact paclitaxel-eluting balloon line, which includes four different balloon platforms. Previous trials conducted on the superficial femoral artery and coronary arteries have shown outcomes favoring drug-eluting balloons, the company stated.