FDA Approvals: PulmoLife, Protege GPS, MuGard

Yael Waknine

February 12, 2007

February 12, 2007 (updated April 15, 2007) — The US Food and Drug Administration (FDA) has approved a spirometry screener for use as an aid in the early detection and diagnosis of chronic obstructive pulmonary disease, a carotid stent for use with a second-generation embolic protection device to treat carotid disease in high-risk patients, and a mucoadhesive oral wound rinse for the management of oral mucositis/stomatitis and other types of oral wounds.

Hand-Held Spirometry Device ( PulmoLife) for Early Detection of COPD

On December 14, the FDA approved a spirometry screening device ( PulmoLife, made by VIASYS Respiratory Care, Inc) to measure lung function parameters. The results can be used as an aid in the early detection and diagnosis of chronic obstructive pulmonary disease (COPD) in adult smokers.

The battery-operated hand-held portable device uses a unidirectional rotating vane, flow-sensing turbine to evaluate lung function parameters, such as forced expiratory volume in the first second of inspiration (FEV 1) and FEV 1 as a percentage of predicted value. Lung age estimation is also provided.

According to a company news release, spirometry is the most sensitive test of lung function and can detect COPD long before significant symptoms are expressed. COPD is currently the fourth leading cause of death in the United States and is projected by the Centers for Disease Control and Prevention to be the third leading cause of death by the year 2020.

In addition to the estimated 16 million individuals in the United States diagnosed with COPD, an additional 14 million remain undiagnosed. The company expects that use of the device may encourage smokers to recognize ongoing damage and encourage them to seek smoking cessation advice and appropriate treatment.

The company notes that although smokers are at increased risk for COPD, breathing in other types of lung irritants (eg, pollution, dust, and chemicals) over a long period of time may also cause or contribute to the disease.

Carotid Stent (Protégé GPS) for Carotid Disease in High-Risk Patients

Editor's note: ev3, Inc, has notified Medscape that is not marketing the Protégé GPS for the carotid indication, although it did receive approval for that use. It is only marketed as a biliary stent.

On January 24, the FDA approved a carotid stent (Protégé GPS, made by ev3, Inc) for use with the company's embolic protection device (SpideRX) for the treatment of carotid disease in patients at high risk for adverse events from carotid endarterectomy.

The self-expanding stent is constructed of nitinol tubing laser-cut into a mesh shape, and comes premounted on a 6-French, 0.014"/0.018" over-the-wire delivery system with tantalum radiopaque markers at either end.

The device is intended for use in patients with carotid artery stenosis (50% or more for symptomatic patients; 80% or more for asymptomatic patients by ultrasound/angiography) and a reference vessel diameter ranging from 4.5 to 9.5 mm at the target lesion.

According to a company news release, the approval was supported by data from the multicenter, prospective, nonrandomized Carotid Revascularization with ev3, Inc, Arterial Technology Evolution (CREATE) trial (n = 419), showing that concomitant use of the device compared favorably with performance criteria based on results of previous carotid stenting trials.

The second-generation embolic protection system was previously approved by the FDA in February 2006 and features a complete rapid exchange system, 6-French guide catheter compatibility, and a dual-end delivery/recovery catheter with a preloaded capture wire.

Both devices are commercially available in Canada, the European Union, and several countries in Latin America and Asia.

Mucoadhesive Oral Wound Rinse ( MuGard) for Mucositis/Stomatitis and More

On December 11, the FDA approved a mucoadhesive oral wound rinse ( MuGard, made by Access Pharmaceuticals, Inc) for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.

When swirled gently in the mouth, the viscous formulation forms a protective coating over the mucosa.

According to a company news release, oral mucositis affects approximately 90% of patients undergoing radiation treatment for head and neck cancer and 20% to 50% of those receiving cytotoxic chemotherapy for various other cancers; however, no well-accepted treatment has been available for the condition thus far. Current solutions include frequent mouth cleansing, rinsing with buffered saline and fluoride solutions, and administration of topical and systemic antimicrobial agents.

The approval was based on data from a clinical study of the product in head/neck cancer patients in which results were compared with 2 difference sources for patients at risk of developing mucositis and who had received previous standard-of-care treatment.

In both cases, mucositis scores were lower for patients using the mucoprotective oral rinse compared with those for similar patients receiving standard care, as evaluated using the oral mucositis assessment scale (OMAS). Patients began using the product on the first day of therapy and continued to do so throughout their cancer treatment.

Results showed that 43% of patients receiving the oral rinse experienced no mucositis (OMAS score ≤ 0.5) compared with 7% in the historical control group. Moreover, those who did develop mucositis experienced a significant decrease in its severity and duration compared with no treatment or standard-of-care practice.


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