Endologix Gets EU Approval for New System

Irvine, Calif.-based Endologix Inc. has been granted CE mark approval to market its new version of the Nellix endovascular aneurysm sealing (EVAS) system for the treatment of patients with abdominal aortic aneurysms (AAAs). The system’s previous incarnation received CE mark in October 2012; the enhancements were related to issues with limb patency that emerged just before the first European Union approval. EVAS with Nellix is designed to simplify endovascular AAA procedures, treat a broad range of patients, and provide enhanced clinical outcomes. The Nellix System is not approved in the United States either for investigational use or commercial sale.

Endologix expects to begin a limited market introduction of the Nellix System in Europe during the second quarter of 2013. The company also will initiate a post-market clinical study of the Nellix System beginning in the third quarter of 2013 in European centers.

“We are very excited to receive CE mark for the Nellix System, which will allow Endologix to introduce the world’s first AAA endovascular aneurysm sealing system to physicians and patients in Europe,” said John McDermott, president and CEO. “We believe Nellix has the potential to simplify AAA procedures, treat a broad range of patients and improve clinical outcomes. The initial commercial activity for Nellix will begin in the second quarter 2013, with a focus on building the clinical experience in collaboration with thought-leading physicians. We will also begin a post-market clinical study, to gather additional data and patient follow-up to support gradual introductions in other markets. The physicians at the initial clinical sites will collect this data and also help us train other physicians as we gradually roll-out Nellix over the course of the year, with a broader launch anticipated in 2014.”

McDermott added that the company is “well positioned” in Europe with its AFX endovascular AAA system, and is expecting CE marking of its Ventana fenestrated system, an aortic extension intended to be used with AFX. Ventana has an investigation device exemption in the United States through the U.S. Food and Drug Administration (FDA).

Endologix develops and manufactures minimally invasive treatments for aortic disorders.

Luminex Releases GI Assay in United States
Austin, Texas-based Luminex Corporation has been granted U.S. Food and Drug Administration 510(k) clearance for its xTAG gastrointestinal (GI) pathogen panel (GPP) molecular diagnostics assay. According to the company, the assay tests for more than 90 percent of bacterial, viral, and parasitic causes of infectious gastroenteritis in a single assay. The xTAG GPP assay can be an important clinical tool in the management of gastrointestinal infections, Luminex claims, and now is available in the United States.

Diarrheal disease occurs more than 2 billion times globally each year and is a leading cause of sickness and death among the world’s children. In the United States alone, 99 million cases of GI infection occur annually, leading to more than 250,000 hospitalizations (according to data from the Cleveland Clinic) and 17,000 deaths (according to data from the Centers for Disease Control and Prevention). Diagnosis of some causes of infectious gastroenteritis traditionally has required multiple tests across microbiology, virology, and molecular laboratories for which results may not be available for several days.

xTAG is a nucleic acid-based amplification assay that simultaneously tests for 11 of the most common gastroenteritis-causing viruses, bacteria, and parasites. The panel includes Campylobacter, Clostridium difficile Toxin A/B, Escherichia coli O157, Enterotoxigenic E. coli (ETEC) LT/ST, Shiga-like toxin producing E. coli (STEC) stx1/stx2, Salmonella, Shigella, Rotavirus A, Norovirus GI/GII, Giardia lamblia and Cryptosporidium.

Depending on the pathogen, currently available technologies and testing methods can take several days to deliver results. The xTAG GPP reportedly is capable of producing results within five hours and is cleared on the Luminex 100/200 analyzer system. Additionally, simultaneous molecular testing on a single sample within a single shift provides significant benefit to laboratories in terms of workflow and resource utilization, Luminex claims.

“In our experience, simultaneous testing for multiple GI pathogens during routine clinical testing and outbreak investigations enhances our diagnostic capabilities and public health laboratory efficiency,” said Sanjib Bhattacharyya, Ph.D., deputy laboratory director at the Milwaukee, Wis., Health Department. “Routine use of xTAG GPP will allow cost-effective, timely detection of multiple pathogens, optimize use of laboratory resources, and elevate our understanding of pathogen-associated diseases in gastroenteritis.”

“xTAG GPP has the potential to enable hospitals to improve patient outcomes while saving money,” said Patrick J. Balthrop, president and CEO of Luminex. The xTAG GPP has been CE marked for sale in Europe and, according to Balthrop, has provided “significant improvement to laboratories and healthcare systems” in the countries where it is approved.

Luminex develops, manufactures and markets biological testing technologies for the diagnostic and life science industries.

FDA Approves Covidien Combination Product to Treat Spasticity
The U.S. Food and Drug Administration has approved Covidien plc’s Gablofen prefilled syringes. Gablofen (a brand name of baclofen) is primarily used to treat spasticity and is in the early research stages for use for the treatment of alcoholism. The prefilled syringes reportedly are designed to cut down on preparation time and make it easier for patients on intrathecal (when a drug is introduced under the arachnoid membrane of the brain or spinal cord) Baclofen therapy. Gablofen is specifically targeted at spasticity traced to spinal and cerebral causes, and is marketed under Covidien’s pharmaceuticals brand Mallinckrodt. Prefilled syringes of Gablofen will be marketed beginning in February. It will be sold in vials of various concentrations.

Covidien is headquartered in Dublin, Ireland. The firm’s U.S. base is in Mansfield, Mass. The company has been quite acquisitive in the past year, scooping up several companies with the aim of diversification and development of new products and technologies. In October last year, Covidien’s pharmaceuticals business Mallinckrodt acquired CNS Therapeutics Inc., a St. Paul Minn.-based specialty pharmaceutical company, for approximately $100 million. Covidien plans to spin-off its pharmaceutical business by mid-2013 to focus on its high-margin surgical products portfolio.

FDA OKs Range of Indications for Depression Treatment Device
Brainsway Ltd., a Jerusalem, Israel-based provider of transcranial magnetic stimulation (TMS) systems for the treatment of neurological and psychopathological disorders, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for a system that treats depression. The Deep TMS device is designed for depressed patients who do not respond to therapy.

TMS involves non-invasive but specific stimulation of brain tissue using brief magnetic pulses.

Company officials note the FDA’s cleared indications for the Deep TMS device are particularly broad, which could be indicative of the device’s efficacy in treating depression and a milestone for changing treatments for the disorder. U.S. regulatory approval opens up a potential billion-dollar market to Brainsway.

According to a company statement, Brainsway executives are considering how to market and distribute the Deep TMS device in the United States and other countries, including collaborations with companies that have experience in the business.

FDA Approves Abbott Drug Eluting Stent System
The U.S. Food and Drug Administration has granted Abbott Laboratories pre-market approval for its next-generation Xience Xpedition drug eluting stent system. The company plans to launch the product in the United States immediately. Xience Xpedition is intended to optimize drug deliverability, particularly in challenging coronary anatomies, and reportedly has the largest size range of any drug eluting system currently on the market.

“Xience Xpedition represents a combination of deliverability, strong clinical data and broad availability of meaningful sizes—three factors that make this product well-suited to treat a wide range of patients,” said Samin K. Sharma, M.D., director of clinical and interventional cardiology, dean of international clinical affiliations, and president of the Mount Sinai Heart Network at Mount Sinai Medical Center in New York, N.Y. Sharma was the first doctor to implant the Xience Xpedition in an American patient. “The impact of the changes to the stent delivery system is particularly notable in patients with complex coronary anatomy. For these patients, physicians have a new technology to reach the blockage and restore blood flow with ease and confidence.”

Abbott claims its Xience line of drug eluting stents—including the Xpedition—are the first and only drug eluting stents in the U.S. market that have proven to be safe for direct stenting. Direct stenting, a technique in which the stent system is not preceded by another device (such as a balloon dilatation catheter) to prepare the lesion, has the potential to save time and resources in the catheterization laboratory. The Xience Xpedition is supported by clinical evidence from the Xience family of drug eluting stents, including data from more than 45,000 patients in more than 100 studies, with long-term outcomes of up to five years.

“The launch of Xience Xpedition in the United States will advance Abbott’s worldwide position in drug eluting stents,” said John M. Capek, Ph.D., executive vice president of medical devices at Abbott. “Xience Xpedition leverages the strong clinical outcomes of Xience V and Xience Prime while providing important advantages in deliverability. With its redesigned stent delivery system and a full matrix of sizes, Xience Xpedition provides physicians with a comprehensive, trusted option to treat a broad range of patients with coronary artery disease.”

In the United States, Xience Xpedition will be available with both rapid exchange and over-the-wire configurations, which are the most popular delivery platforms. Xience Xpedition has diameters ranging from 2.25 millimeters to 4 millimeters, including a special 3.25-millimeter diameter, and lengths from 8 millimeters to 38 millimeters, for more accurate vessel sizing.

Abbott Vascular, a division of Abbott, will market the devices. Based in Abbott Park, Ill., Abbott produces healthcare devices for various medical applications. Abbott Vascular’s portfolio includes products for coronary artery disease, vessel closure, endovascular disease and structural heart disease.