A Medical Device Daily

Masimo (Irvine, California) reported Japanese Ministry of Health, Labor and Welfare (MHLW) approval of its PVI measurement.

PVI is an index derived from the Masimo plethysmographic waveform, which the company said has been demonstrated to noninvasively assess fluid responsiveness in mechanically ventilated patients and can help clinicians assess if a patient's cardiac function is compromised.

The company said PVI "may help clinicians and emergency professionals to determine if a patient is dehydrated or over-hydrated enabling more accurate fluid administration decisions all by simply referring to the numerical Masimo PVI value that is continuously displayed on Masimo Rainbow SET pulse CO-oximeters."

It said that with one noninvasive sensor, Masimo Rainbow SET technology delivers multiple physiologic measurements that previously required invasive blood tests, including total hemoglobin and oxygen content, carboxyhemoglobin, methemoglobin, PVI, oxyhemoglobin, perfusion index and pulse rate.

Masimo said that during surgery and post-operatively, the immediate identification and rapid intervention of patients who are most likely to respond to fluid administration can enable organ preservation, while recognizing patients unlikely to respond to fluid administration can prevent pulmonary edema.

It said clinical studies have shown that current static methods for assessing fluid responsiveness, including clinical examination, arterial blood pressure, heart rate and central venous and pulmonary artery occlusion pressure, "are poor predictors of fluid responsiveness."

The company calls PVI "a dynamic new indicator of fluid responsiveness that does not require an invasive procedure or manual calculation, yet has been demonstrated to be sensitive to changes in preload and to be an accurate predictor of fluid responsiveness in mechanically ventilated patients."

CE mark for PTCA dilatation catheter

OrbusNeich (Hong Kong) reported receipt of the CE mark for its Sapphire 1.25 mm PTCA dilatation catheter.

Scheduled for immediate rollout to the interventional cardiology community, Sapphire 1.25 mm is a small-diameter balloon catheter that OrbusNeich said is "designed specifically for the pre-dilatation of tight, calcified chronic total occlusion (CTO) lesions that require the best crossability."

The company said the product "provides physicians with enhanced pushability and superior kink resistance." It said the Sapphire 1.25 mm is the only balloon available in a 5 mm length, and 8 mm, 10 mm and 15 mm lengths also are offered.

"The Sapphire 1.25 mm balloon is easily deliverable with good pushability, and may be considered a first choice in highly stenotic lesions," said Tan Huay Cheem, MD, of University Hospital in Singapore.

OrbusNeich manufactures devices for the treatment of vascular diseases, including the Genous Bio-engineered R stent, an antibody-coated device that is the first stent to capture a patient's endothelial progenitor cells to accelerate the natural healing process following placement.

In addition to its Hong Kong headquarters, OrbusNeich has operations in Fort Lauderdale, Florida; Hoevelaken, the Netherlands; Tokyo; and Shenzhen, China.

U.S. trial starts for MediGuide/Philips product

MediGuide (Haifa, Israel) and Royal Philips Electronics (Amsterdam, the Netherlands) said they have started their planned clinical trials in the U.S. using the Philips Integris Allura Flat Detector catheterization lab (Allura FD-10) integrated with MediGuide's Medical Positioning System (gMPS) technology.

The trial at Columbia-New York Presbyterian Hospital (New York) is being conducted under an investigational device exemption (IDE) and uses the MediGuide gMP Enabled Guided Measurement Catheter (GMC) with the integrated Philips-MediGuide technologies. The gMPS system and GMC device are CE-mark certified and are limited to investigational use only in the U.S.

Philips and MediGuide have been cooperating since 2003 in the field of cardiac navigation. The gMPS system is used for intravascular evaluation of coronary anatomy and is intended to enable real-time tip positioning and navigation of a gMPS-enabled diagnostic or therapeutic device used in coronary or cardiac intervention in the cath lab environment, on both live fluoroscopy or recorded background.

The system is indicated for use as an adjunct to coronary angiography.

The gMPS-enabled GMC intravascular device is intended to be used in conjunction with conventional X-ray angiography systems to enable real-time tip positioning and navigation, quantitative length measurement, 3-D lumen reconstruction, qualitative 3-D foreshortening indication and landmarking, in patients who are candidates for coronary angiography and/or percutaneous coronary intervention.

MediGuide, a company originally spun off from Elbit Systems, is a provider of technology, solutions and applications for intra body navigation and less-invasive procedures, with a focus on cardiology.

Sonomed gets China SFDA approval

Escalon Medical (Wayne, Pennsylvania) said its Sonomed subsidiary has received approval from the State Food and Drug Administration of China to market the PacScan and E/Z-Scan lines of products in that country.

The PacScan line consists of A-scans, pachymeters and combination systems used in both cataract and refractive surgery. The E/Z- Scan line consists of both B-scan and A/B-scan systems for enhanced diagnostic capabilities. Both systems are widely marketed internationally and have become some of the best-selling ophthalmic biometry and ultrasound imaging systems in the world, according to Escalon.

The company said has immediate plans to market both series of instruments through its two existing distributors in mainland China, the Hwa-In Group and Shenzhen K&K, and also plans to increase its direct support network to assist distributors, attend regional meetings, and provide training as needed.

Barry Durante, president of Sonomed, said, "These instruments will provide physicians the opportunity to offer a safe and accurate ultrasound examination to improve their diagnostic capability and patient surgical outcomes."