A Medical Device Daily

Four device companies met the Nov. 19 application deadline for special payments for new services or technologies under the Acute Care Hospital Inpatient Prospective Payment System, according to the Centers for Medicare & Medicaid Services (CMS; Baltimore).

In the fiscal 2009 inpatient payment rule, the following companies are seeking new technology payments for devices: FzioMed (San Luis Obispo, California) for its Oxiplex spine surgery gel; TherOx (Irvine, California) for its Downstream SuperSaturatedOxygen therapy system; Emphasys Medical (Redwood City, California) for its Zephyr enobranchial valve; and SynCardia Systems (Tucson, Arizona) for its CardioWest temporary total artificial heart.

According to the application form, companies must show that the new device represents a "substantial clinical improvement" over existing therapies in order to qualify for a new technology add-on payment.

CMS said its proposed decision on the add-on payments would be in the draft inpatient rule, to be released in the spring and finalized in the FY09 rule expected in August.

The FY08 inpatient rule included no new-technology add-on payments.

FzioMed reported in October that its PMA application for its Oxiplex spine surgery gel had been accepted for filing and granted expedited review by FDA (Medical Device Daily, Oct. 9, 2007). Oxiplex is intended to reduce pain and symptoms following lumbar spine surgery. It is an absorbable gel used during lumbar laminectomy, laminotomy and discectomy surgical procedures. The gel is applied around the sensitive spinal nerve root and surrounding neural tissues, creating a protective environment during post-surgical healing. According to FzioMed, Oxiplex does not interfere with normal healing and clears naturally from the body. The company expects FDA approval by April 2008.

TherOx's Downstream system to treat heart attacks is designed to deliver aqueous oxygen (AO) - that is, oxygen dissolved in physiologic solution at high concentrations. It contains hyperbaric levels of oxygen and can be delivered through a catheter to targeted locations in the bloodstream (MDD, Oct. 14, 2004). TherOx expects FDA approval of the device in the 2Q08 based on results of its 301-patient AMIHOT II trial, which demonstrated that the system reduced infarct size by an average of 6.5%, the company noted on its application.

Emphasys Medical last month reported that its pre-market approval (PMA) application for its Zephyr EBV was granted expedited review by FDA (MDD, Nov. 2, 2007). The device - a small one-way silicone valve - is intended to mitigate the effects of emphysema by isolating the targeted diseased portion of the lung, causing a reduction in volume of the diseased region and allowing the healthier portions of the lung to function more normally.

SynCardia received FDA approval for its CardioWest in October 2004 as a bridge to heart transplantation (MDD, Oct. 19, 2004). Specifically, the device is approved for use in cardiac transplant-eligible patients at risk of imminent death from non-reversible biventricular failure.