For my money, one of the funniest scenes in the classic movie Monty Python and the Holy Grail is when a medieval peasant brings out his old father to the undertaker, only to have the father reveal that he is "not quite dead." Despite vehement denials by the son, the father repeatedly protests, "I’m not dead!"
Latest News on MassDevice
FDA-CMS parallel review: Charm offensive or meaningful change?
As regular readers of MassDevice.com already know, the Sept. 17, 2010, Federal Register contained a request for comments on a proposal to initiate parallel review of medical products by the Food & Drug Administration and the Centers for Medicare and Medicaid Services (PDF).
Hologic, Henry Schein win multi-million-dollar military contracts
Hologic Inc. (NSDQ:HOLX) won a $32.3 million contract with the U.S. Dept. of Defense for its pap tests and supplies related to the kits, while Henry Schein Inc. (NSDQ:HSIC) landed a $28.8 million deal for general dental supplies.
Bedford, Mass.-based Hologic was the only bidder for its year-long contract, which calls for it to supply the the Army, Navy, Air Force and Marine Corps with its ThinPrep test kits for human papilloma virus, according to the Defense Dept.
ECI Biotech inks pathogen sensor deal with Systagenix
ECI Biotech Inc. signed a licensing and manufacturing agreement with Systagenix Wound Management Inc.
Worcester, Mass.-based ECI Biotech makes protein-based, point-of-care bacterial sensors and will collaborate with Quincy, Mass.-based Systagenix to develop a diagnostic technology for treating chronic wounds.
The companies said the resulting product will enable early infection detection and cheaper care by reducing unnecessary blanket treatments.
Athersys touts positive results for stem cell treatment for heart attack patients
Athersys Inc. (NSDQ:ATHX) reported more positive results from an ongoing Phase 1 clinical trial of its adult stem cell therapy for the treatment of heart-attack patients.
The new data show that Athersys’ MultiStem treatment was well-tolerated at all dose levels and also suggest improvement in heart function in treated patients. The newly announced results are based on four months of data on patients who were treated with MultiStem after suffering acute myocardial infarctions, or heart attacks, according to the company.
TCT 2010 roundup: Abbott keeps after Boston Scientific’s Taxus
Abbott (NYSE:ABT) kept up the pressure on Boston Scientific Corp. (NYSE:BSX) at a high-profile cardiology conference, releasing data from a pair of studies it says show that its Xience V drug-eluting stent is better than Boston Scientific’s competing Taxus.
Two-year data from the head-to-head trials of the paclitaxel-eluting Taxus against the everolimus-eluting Xience stent showed that more patients treated with BSX’s stent developed late-stent thrombosis. The data were presented in Washington, D.C., at the annual Transcatheter Cardiovascular Therapeutics conference.
MYTHOS RenalGuard Trial Demonstrates Greater Efficacy Than Current Standard of Care
PRESS RELEASE
PLC Systems Inc. (OTC:PLCSF), a company focused on innovative cardiac and vascular medical device-based technologies, today announced that updated results from the MYTHOS investigator-sponsored clinical trial of RenalGuard in Italy showed that RenalGuard was more effective than the current standard of care at preventing Contrast Induced-Nephropathy (CIN). In scientifically significant results presented at Transcatheter Cardiovascular Therapeutics (TCT) 2010, the investigators found that patients treated with RenalGuard developed CIN, a serious and potentially fatal condition, at much lower rates than patients in the control group who were treated with overnight hydration, the current gold standard therapy.
LEADERS Three-Year Results Suggest Improved Safety and Efficacy of BioMatrix Flex over Cypher Select
PRESS RELEASE
Biosensors International Group, Ltd ("Biosensors", "Company", BIG:SP) today announced three-year results of the LEADERS trial, which showed a continuing positive trend towards a safety and efficacy benefit for BioMatrix Flex, Biosensors’ Biolimus A9-eluting stent system with abluminal biodegradable polymer, compared to Cypher Select, Johnson & Johnson’s sirolimus-eluting stent system with a durable polymer. Results were presented by Professor Patrick W. Serruys, Erasmus Medical Center, Netherlands, at the 22nd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation.
Novel Drug-Eluting Stent System for Treatment of Small Vessels Demonstrated Safe and Effective at Eight Months
PRESS RELEASE
Biosensors International Group, Ltd ("Biosensors", "Company", BIG:SP) today announced 8-month results from the CARE II Study, which showed that its novel Sparrow drug-eluting stent system, developed by recently-acquired CardioMind, Inc., is both safe and effective in the treatment of small vessel lesions. These results were presented by the Principal Investigator, Dr. Alexandre Abizaid, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, at the 22nd annual Transcatheter Cardiovascular Therapeutics ("TCT") scientific symposium, sponsored by the Cardiovascular Research Foundation.
OrbusNeich’s Genous Bio-engineered R stent Shows Favorable Safety Profile and Clinical Outcomes in Combination with Paclitaxel-Coated Balloon for De Novo Coronary Artery Disease
PRESS RELEASE
OrbusNeich today announced that six-month follow-up clinical trial data demonstrate the excellent safety profile and efficacy of the company’s Genous Bio-engineered R stent in combination with a paclitaxel-coated balloon for the treatment of de novo coronary artery disease. The data were presented by Jochen Woehrle, M.D., University of Ulm, Germany, principal investigator of the study, in the first report clinical trial session at Transcatheter Cardiovascular Therapeutics (TCT) 2010 in Washington.
Abiomed Reports Updated USpella Results at TCT 2010
PRESS RELEASE
Abiomed, Inc. (NSDQ:ABMD), a leading provider of breakthrough heart support technologies, today announced updated clinical data from USpella, a U.S. multicenter, observational registry of Impella 2.5 patients.
The new updates, presented today at TCT 2010 reported that 24 U.S. and Canadian centers have contributed data for a total of 352 patients. The USpella registry results were last announced on May 15, 2010 at EuroPCR 2010.