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Biomerix of Fremont, CA has received FDA clearance for its ventral hernia repair mesh. The mesh has two different sides, one covered with Biomerix Biomaterial, which promotes tissue ingrowth, and on the other side a resorbable protective film which minimizes tissue attachment of the viscera. The Biomerix Biomaterial mimics the natural extracellular matrix, consisting of a three-dimensional, open-cell, macroporous structure that selectively adsorbs plasma and proteins. This stimulates cells to migrate and attach to the material. Indications for the mesh are hernia repair, soft tissue deficiencies and temporary bridging of fascial defects.

Press release: Biomerix Ventral Hernia Repair Mesh Receives FDA 510(k) Clearance…

Company website: Biomerix

SurgiVision has received FDA clearance for its ClearPoint system for MR guided neurological interventional procedures. It allows for precise targeting of lesions within the brain. The system consists of a disposable, MRI-compatible head-mounted adjustable trajectory frame; a multi-channel imaging head coil with integrated head fixation frame; a workstation and an MRI compatible computer and monitor with navigational software; and lastly, a complete MRI compatible surgical kit. The system can be used in existing MRI suites.

Demo video here…

Press release: DARA BioSciences Reports on SurgiVision Receiving FDA Clearance to Market Its ClearPoint System…

Product page: SurgiVision ClearPoint…

Out of San Diego, CA, Volcano Corporation has announces 510(k) clearance, CE Mark approval, and first clinical use for the PrimeWire PRESTIGE Pressure Guide Wire for use in patients who have both single-vessel and multi-vessel coronary artery disease. The next-generation guidewire provides functional measurements of blood pressure and flow parameters from inside the vessel to aid physicians in multi-vessel disease decision-making.

From the press release:

The PrimeWire PRESTIGE™ Pressure Guide Wire has a redesigned core intended to improve mechanical performance, such as torque transmission, vessel navigation, and support. A recent internal study confirmed that PRESTIGE™ substantially outperformed the previous generation PrimeWire® with respect to torque transmission. The redesigned tip also improves tactile feel and tip shape memory. PrimeWire PRESTIGE™ will launch simultaneously with the new upgraded v3.2 Software for the Volcano s5i, which provides an optimized FFR workflow for ease of use.

"The clinical data from the FAME study supporting the use of FFR to guide stent placement in multi-vessel disease patients is very strong, and has led to the upgrade of ACC/AHA/SCAI guidelines to level of evidence A," commented Dr. Mort Kern, Chief of Cardiology for the VA Long Beach Health System and Associate Chief of Cardiology at UC-Irvine Medical Center. "One key hurdle that physicians continuously battle with is the accurate and efficient diagnosis of lesion significance at the time of the procedure. Any improvement to the performance of today’s FFR wires that make assessment of multi-vessel disease lesions easier and faster is a welcome change to physicians."

Press release: Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire…

Volcano Corp…

Digirad Corp. of Poway, CA has received 510(k) clearance from the FDA to begin marketing its Ergo mobile nuclear imaging system. Thanks to its solid-state gamma camera, the Ergo provides a degree of portability and flexibility not previously seen in the field. Imaging studies can be conducted in the nuclear medicine department or brought to the patient, saving time and improving patient satisfaction while delivering high quality results. The large field, solid-state gamma camera also expands the reach of portable nuclear imaging to areas outside cardiology and oncology, offering a 12.25 x 15.5 inch field of view, an intrinsic spatial resolution of 3.25 mm, an energy resolution of 7.9%, and 5 Mcps.

Digirad plans to begin shipping production units in June to hospitals in the US and abroad.

Press release: Digirad Receives FDA Clearance for Ergo Large Field-of-View, Solid-State, General Imaging Nuclear Medicine Camera…

Link: Digirad…