FDA Approvals: Protege RX, Duet, Mesomark

Yael Waknine

January 29, 2007

January 29, 2007 — The US Food and Drug Administration (FDA) has approved a carotid stent for use with a second-generation embolic protection device to treat coronary artery disease; a new indication for an automated scanning and image analysis system, allowing its use to assess the eligibility of breast cancer patients for trastuzumab therapy; and a blood test for use as an aid in the management of patients diagnosed with mesothelioma.


Carotid Stent (Protégé RX) for Coronary Artery Disease in High-Risk Patients

On January 24, the FDA approved a carotid stent (Protégé RX, made by ev3, Inc) for use with the company's embolic protection device (SpideRX) for the treatment of coronary artery disease in patients at high risk for adverse events from carotid endarterectomy. It is available in both straight and tapered configurations to address individual patients' anatomy.

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 devices 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 EU, and several countries in Latin America and Asia.


Automated Scanning/Image Analysis System (Duet) for Use on Breast Cancer Tissue

On January 25, the FDA approved a new indication for an automated scanning microscope and image analysis system (Duet, made by BioView, Ltd), allowing its use to detect and quantify chromosome 17 and the HER-2neu gene via fluorescence in situ hybridization in interphase nuclei from formalin-fixed, paraffin-embedded breast cancer biopsy tissue specimens probed by the Pathvysion HER-2 DNA probe kit (made by Vysis, Inc [a wholly owned subsidiary of Abbott Laboratories, Inc]).

The system aids pathologists in the detection, classification, and counting of cells based on color, intensity, size pattern, and shape. For this application, the HER-2/neu gene to chromosome 17 ratio is used to assess the eligibility of patients with metastatic breast cancer for treatment with trastuzumab (Herceptin, made by Genentech, Inc), which is indicated for the treatment of HER-2–positive tumors.

The automated system was previously approved by the FDA for use with the UroVysion bladder cancer kit (made by Vysis, Inc) to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus in patients with potential recurrence of transitional cell bladder cancer.

The system may also be used as an in-vitro diagnostic tool and monitoring device for hematologic pathologies by immunohistochemistry analysis of Giemsa-stained hematopoietic cells, and for the diagnosis and monitoring of patients with genetic abnormalities in chromosomes X, Y, 13, 18, and 21 using direct-labeled DNA probes.


Blood Test (Mesomark) for the Management of Mesothelioma

On January 25, the FDA approved a blood test for mesothelioma (Mesomark, made by Fujirebio Diagnostics, Inc) under the humanitarian device exemption program.

According to a company news release, the test is the first in-vitro assay for mesothelioma. The enzyme-linked immunosorbent assay measures soluble mesotheline-related peptides (SMRP) that are produced by the cancer cells and serve as a biomarker for the disease. Test results directly correlate with tumor volume.

The current approval limits use of the test to the management of patients diagnosed with biphasic or epithelioid mesothelioma; it can be used to monitor patients for recurrence after surgery or to measure therapeutic response.

The test will be available to US physicians via a central reference laboratory in the first quarter of 2007, the company said. The blood test was previously approved for use in the European Union and Australia.

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