St. Jude Medical's ($STJ) now-recalled Riata and Riata ST cardiac defibrillator leads fail more often over the long-term than rival products, according to newly-published research. The news, featured in the journal HeartRhythm, reinforces the sense of urgency behind company's 2011 Class I recall of the products. Riata leads remain in about 79,000 patients.

As MedPage Today points out in its coverage of the research, scientists at the University of California, San Francisco completed their study prior to the recall. But it is an important work because it confirms concerns over the ICD leads' higher electrical failure rate, backing up subsequent studies with similar conclusions. The researchers urge providers to monitor patients who still have the Riata leads very carefully "in order to prevent inappropriate shocks or failed device interventions," according to the article. And they recommend using "large-scale remote monitoring" to keep an eye on these patients.

Another finding: The research team addresses the Riata recall fallout for patients who still have the lead. They note that placing new leads and abandoning the old ones without removing them appeared to be a safe option for patients based on about 18 months of follow-up.

According to the study, Riata leads experienced a 97.5% survival rate. That's much lower, for example, than the 99.2% rate generated by Medtronic's ($MDT) Sprint Quattro Secure leads and the 99.5% produced by Boston Scientific's ($BSX) Endotak Reliance G/SG leads, the story notes. At the same time, however, Riata leads' survival rate still landed higher than Medtronic's Sprint Fidelis, which placed at 89.6% and faced a 2009 recall because of potential for fractured leads. Researchers conducted their retrospective analysis involving 24,300 patients with remote transmissions from 2002 to 2012.

St. Jude said its implantable cardioverter-defibrillator product sales dipped 4% in the 2012 second quarter, dropping to $746 million. The company is also investigating Riata risks on its own.

- read the MedPage Today story
- check out the journal abstract

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Luminex has signed an $11.6 million deal with the Department of Defense, tasked with developing a hand-held diagnostics tool that can detect biothreat agents.

The 42-month contract is with the DoD's Defense Threat Reduction Agency, requiring Luminex to create a prototype device that can identify biomarkers of Systemic Inflammatory Response Syndrome, a result of blood infection common on the battlefield and in biowarfare.

Biothreat microbes are varied and tough to diagnose, according to Luminex, but the company identified some common factors of blood infection that will it allow to create an assay that can detect both biowarfare pathogens and other impurities. "The flexibility and scalability of our multiplexing technology allow for the measurement of RNA, DNA and proteins with the same system, aiding rapid and accurate diagnosis of these severe conditions," said Amy Altman, vice president Luminex Biodefense, in a statement.

And Luminex has the technology to fulfill the agreement, thanks in part to recent M&A. Last month, the Austin-based firm acquired GenturaDx for $50 million, gaining that company's rapid-result assay tech, and, in 2011, Luminex spent $34 million on EraGen Biosciences, absorbing that company's MultiCode-RTx test.

- read Luminex's statement

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BG Medicine ($BGMD) pulled the 510(k) submission for its CardioScore diagnostic test this week because it couldn't meet an FDA deadline for requested information, and investors punished the company in turn. Of course, widening 2012 second-quarter losses didn't help matters.

As the Boston Business Journal and others reported, the Waltham, MA-based diagnostics company saw its stock price drop about 6% on the negative news, before slightly rebounding to $6.49 per share at the end of trading on Aug. 9.

BG Medicine said it withdrew its 510(k) application for its CardioScore blood test for cardiovascular disease because it didn't meet an Aug. 15 FDA deadline to confirm certain study data obtained through medical insurance claims. The company was careful to note that its approach is "a method previously validated in numerous peer-reviewed studies." No new submission data is planned yet, the company said, until it is "satisfied that the information requested by the FDA is addressed in the new submission."

Meanwhile, BG Medicine noted, it is plowing ahead with expansion plans for the company's BGM galectin-3 heart failure diagnostic test franchise. A separate 510(k) submission is pending for the company's Architect galectin-3 assay, and another 510(k) process is underway to gain expanded clearance to use the BGM galectin-3 test for adult patients at risk of developing heart failure based on elevated galectin-3 levels (an expansion already obtained in Europe through a CE mark). Development partner Abbott ($ABT), meanwhile, is expected to obtain a CE mark in the coming months for an automated version of the BGM galectin-3 test for Europe.

BG Medicine said it lost $6.4 million during the quarter ending June 30, up from a $4.8 million net loss over the same period in 2011, driven in part by higher sales and administrative expenses. As of the end of the second quarter, BG Medicine said it had about $23.3 million in cash, equivalents and securities on hand. BG Medicine just went public last year, and is still ramping up revenue. One bright spot: Product revenue spiked in the second quarter to $566,000, up from $46,000 over the same period in 2011, reflecting increased demand for the BGM galectin-3 test.

- read the release
- check out the BBJ's take
- here's BioCentury's coverage

Special Report: BG Medicine - Biotech IPOs of 2011

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CareFusion ($CFN) turned a $110 million profit in its fiscal fourth quarter, a 29% boost over 2011 and a strong showing in a quarter fraught with recalls and device security concerns.

The company's revenue jumped by 3% on the quarter to $968 million, and CareFusion cut its selling and administrative expenses by 10%. CareFusion notched 9% sales growth in its medical systems unit--including dispensers, infusiors and respiratory devices--and saw a 7% decline in its smaller procedural solutions business.

Perhaps most encouraging for CareFusion was the quarter's 29% sales spike for respiratory products, a unit that has endured three recalls and a security scare over the past few months. In May, the company recalled some models of its AirLife infant breathing device over potential leakage, and, in the same month, CareFusion recalled its Alaris electronic infusion pump over a power supply issue. In June, the company recalled some EnVe ventilators over leakage concerns and faced an IT scare when a website used to update device software was overrun with malware. 

CareFusion ponied up $7 million in recall charges during the quarter, CFO Jim Hinrichs told investors. However, while recalls are impossible to predict, the company is committed to product safety, Hinrichs said.

The company divested its neurodiagnostic business in the quarter, as well, selling the Nicolet unit to Natus Medical for $58 million back in April. That move was designed to help the company streamline its operations and focus on its core business, CEO Kieran Gallahue said in a statement, and the company may look to M&A in the coming years. 

- here are CareFusion's results
- get more from the WSJ

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Echo Therapeutics ($ECTE) is angling to get regulatory approval for its wireless, non-invasive glucose monitor, and the company now has a $20 million line of credit to speed the process, thanks to Platinum-Montaur Life Sciences.

Symphony tCGM is Echo's candidate device, using the company's needle-free drug delivery tech to continuously monitor blood glucose levels in diabetics. The company has yet to file for approval with any regulatory agency, and the credit line will come in handy as Echo tries to get Symphony on shelves around the world, CEO Dr. Patrick Mooney said.

"We believe the increased liquidity and financial flexibility provided by this financial commitment will enhance our ability to aggressively move Symphony toward regulatory clearance in both Europe and the United States," Mooney said in a statement.

Echo, a company tied to MIT's Robert Langer, faced continued delays over the launch of Symphony, initially expecting to get the product on the market in 2011, after hearing from the FDA that it would need only minor tweaks before approval. As it turns out, however, Symphony must go through the Health and Human Services Department's Combination Products Department, Echo told FierceDrugDelivery in March, further prolonging the process.

The extended wait isn't doing Echo any favors financially, either. In the second quarter, the company's net loss widened to $3.2 million, compared to $2 million in the same period in 2011, due in part to Echo's more than doubling its R&D budget.

In any case, Echo has continued to tout positive results for Symphony and its Prelude transdermal tech, and the company is focused on the future, Mooney said. "In the second half of the year, our focus is to establish plans for CE mark and FDA pivotal trials for Symphony, advancing toward European and U.S. regulatory clearances and, ultimately, Symphony's commercial launch," he said.

- read Echo's release
- check out its Q2 results

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