A Medical Device Daily
The LifeCell (Branchburg, New Jersey) subsidiary of Kinetic Concepts (KCI; San Antonio) has been granted CE-mark approval by the company's Netherlands-based notified body, KEMA, for its Strattice Reconstructive Tissue Matrix.
Receipt of the CE mark allows KCI to begin marketing Strattice in all 27 European Union member (EU) states. Strattice received 510(k) clearance from the FDA in June 2007 and the product has been available commercially in the U.S. since February.
Strattice, manufactured using LifeCell's pioneering processing technology, is a porcine-based, acellular dermal matrix that acts as a scaffold that is revascularized and repopulated by the host, ultimately converting the matrix into functional, living tissue.
KCI said the product is recommended for use in a range of applications involving tissue repair to reinforce soft tissue where weakness exists, such as challenging hernia repair and breast reconstruction.
The company said Strattice "has demonstrated rapid revascularization and cell repopulation within two weeks of implantation and a mature vascular structure six months' post-implant in an animal model."
"With the granting of the CE mark for Strattice, KCI has reached another milestone as we pave the way for the broader roll-out of LifeCell products internationally," said Catherine Burzik, president/CEO of KCI. "Strattice's availability within the EU will allow further expansion of our Regenerative Medicine business and demonstrates KCI's commitment to developing innovative therapies that address unmet medical needs of clinicians and their patients around the world."
Strattice is available immediately for surgeons in select EU markets, with the full commercial launch of LifeCell's new reconstructive tissue matrix anticipated in the first half of 2009.
In the five primary EU markets of France, Germany, Italy, Spain and the UK, KCI estimates roughly 100,000 challenging hernia repair procedures and nearly 25,000 breast reconstruction procedures, appropriate for treatment with biologics, are performed annually.
CE mark for automated Lp-PLA2 test
diaDexus (South San Francisco, California), Inc. today announced that it received CE Mark approval for the automated format of the PLAC Test for Lp-PLA2. This automated format of the PLAC Test, capable of running on a wide range of clinical chemistry analyzers, received FDA clearance in December 2007.
diaDexus also reported the first shipment of the CE-marked PLAC Test to Europe.
The company said the PLAC Test is the only blood test cleared by the FDA to assess risk for both coronary heart disease and ischemic stroke associated with atherosclerosis. The test measures lipoprotein-associated phospholipase A2 (Lp-PLA2), a vascular-specific inflammatory enzyme implicated in the formation of rupture-prone plaque. It is plaque rupture and thrombosis, not stenosis, that cause the majority of cardiac events. Clinical research demonstrates that early diagnosis of cardiovascular disease improves the likelihood of preventing these events.
President/CEO Patrick Plewman said, "Over 2 million people in the 27 EU member states die of cardiovascular disease each year; heart disease is the leading cause of death, and stroke is third. Working closely with our distribution partners in the EU, diaDexus is committed to expanding access to the PLAC Test in Europe to help identify individuals at increased risk of suffering a heart attack or stroke."
Wolfgang Koenig, MD, of the University of Ulm (Ulm, Germany), said, "It is well documented that traditional risk factors fail to identify many people at risk for developing cardiovascular disease. The PLAC Test provides us with information we've never had before about a patient's risk for coronary heart disease and ischemic stroke, helping to determine the best course of treatment to prevent these events from occurring."
He added, "Lp-PLA2 has similar predictive power for both primary coronary heart disease in initially healthy subjects, as well as for recurrent events in those with clinically manifest atherosclerosis."
Italian hospital orders Mobetron
IntraOp Medical (Sunnyvale, California) reported that it has received an order for its Mobetron radiation therapy device from Azienda Ospedaliero-Universitaria Ospedali Riuniti Trieste in Northern Italy.
The Mobetron is a mobile device that delivers intraoperative electron-beam radiation therapy (IOERT) to a tumor site during cancer surgery. The Mobetron enables radiation and surgical oncologists to target the exact area that requires radiation and to deliver an effective dose of radiation directly to the affected tissue during surgery.
Since the Mobetron is a mobile, self-shielded device, doctors will be able to move the Mobetron between operating rooms, avoiding the high cost of outfitting radiation rooms to accommodate traditional linear accelerators. Ospedali Riuniti will use the Mobetron to treat many forms of cancer but have acquired the device to specifically expand their treatment for breast cancer.
The radiotherapy facility at Ospedali Riuniti has been treating patients for more than 40 years and has been a leader in implementing new technology for the treatment of cancer. The radiotherapy department currently treats 1,000 patients a year.
Ospedali Riuniti will join a regional program with Centro di Riferimento Oncologico (CRO) in Aviano, Italy, to provide the best cancer treatment possible to the region. CRO adopted the Mobetron in 2007 and is one of the few hospitals in Italy that has been given the status of Institute for Research in the Cure of Cancer and Scientific Study.