Financings In Brief
This article was originally published in The Gray Sheet
Executive Summary
Pathway raises $40 mil. to boost atherectomy catheter roll out: Maker of the Jetstream G2 peripheral atherectomy catheter raises $40 million in a private placement announced March 30. Pathway Medical Technologies will use the proceeds "to continue to build its sales team, grow its manufacturing organization, continue product development and prepare for profitability," the firm says. Jetstream G2 gained 510(k) clearance Jan. 13 "for use in atherectomy of the peripheral vasculature," according to FDA. The device subsequently gained expanded clearance "specifically for use in breaking apart and removing thrombus (or blood clots) from the upper and lower extremity peripheral arteries," the Kirkland, Wash.-based company reported March 23. Jetstream G2 "offers specific design enhancements to Pathway's first-generation device," cleared in October 2008, the firm notes. Until now, peripheral atherectomy devices "have not been effective in removing all types of hard and soft tissue plaque," Pathway claims. Contributors to the latest financing round include Forbion Capital Partners, HLM Venture Partners, Latterell Venture Partners, Oxford Bioscience Partners and Giza Venture Capital
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Research In Brief
CT angiography: Computerized tomographic angiography (CTA) is a safe and effective diagnostic method for ruling out serious cardiovascular disease in patients who come to an emergency department with chest pains, according to the lead author of a long-term study of CTA screening presented May 15 at the Society for Academic Emergency Medicine's annual conference in New Orleans. In the study, led by Judd Hollander, University of Pennsylvania, 481 patients who had no evidence of coronary blockage in a CTA scan were followed for one year. None of the patients had a heart attack or required a coronary revascularization procedure during the follow-up, although 11% were rehospitalized for further cardiac testing. "The ability to rapidly determine that there is nothing seriously wrong allows us to provide reassurance to the patient and to help reduce crowding in the emergency department," Hollander said. According to the Medical Imaging & Technology Alliance, previous research has shown that CTA screening saves $2,500 per patient versus admitting the patient to the hospital for more extensive testing. In a MITA press release, Hollander says: "The evidence now clearly shows that when used in appropriate patients in the emergency department, we can safely and rapidly reduce hospital admission and save money.
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.