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New test system identifies 193 different yeasts and bacteria known to cause illness

The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS can identify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute.

The VITEK MS can identify yeasts such as those from the Candida, Cryptococcus and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceaefamilies, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections. People with immune systems that are compromised or weakened by HIV/AIDS, cancer treatment, or anti-rejection therapy following an organ transplant are particularly vulnerable to these infections.

“The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.”

The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry (MALDI-TOF MS). The technology uses a laser to break yeast and bacteria specimens into small particles that form a pattern unique to the microorganism. The VITEK MS automatically compares the microorganism pattern to 193 known yeasts and bacteria in the test system’s database to identify the microorganism.

Compared to other identification methods that require abundant organism growth for testing, mass spectrometry requires only a small amount of yeast or bacterial growth, so testing can start as soon as growth is visible, generally within 18 to 24 hours. Traditional methods can take up to five days to produce the same identification results.

The FDA reviewed the VITEK MS through its de novo classification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

For the de novo petition, the FDA based its decision on the results of a study of 7,068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctly identified the scientific group or family 93.6 percent of the time (with 87.5 percent of microorganisms identified to species level). The VITEK MS provided a `‘no identification’` result for 3.2 percent of the microorganisms in the study. Of all test results, only 0.8 percent were incorrect and 2.4 percent were low discrimination with no correct result.

The VITEK MS is for clinical use for the identification of microorganisms cultured from human specimens. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

The VITEK MS is manufactured by bioMerieux, Inc. in Durham, N.C.

For more information:
FDA: Medical Devices
FDA: Office of In Vitro Diagnostics and Radiological Health:

C.R. Bard to buy Rochester Medical for $262 million

New York Business Journal
Date: Wednesday, September 4, 2013

Medical device company C.R. Bard Inc. plans to buy Rochester Medical Inc. for $262 million to expand its share of the urology home care market.

Murray Hill, N.J.-based C.R. Bard (NYSE: BCR) has agreed to pay $20 per share for Rochester Medical (Nasdaq: ROCM), a Stewartville, Minn.-based developer of silicone urinary incontinence and urine drainage products.

The price represents a 45 percent premium to Rochester Medical’s closing price of $13.81 a share Tuesday. Shares of Rochester were up 44 percent to $19.92 a share by Wednesday afternoon. Bard shares were up 1 percent to $116.03 a share.

The deal has been approved by the companies’ boards and is expected to close later this year, subject to approval of the shareholders of Rochester Medical and regulatory approvals.

Bard said the acquisition represents a “compelling strategic fit” for Bard and greatly improves its position in a $930 million global urology home care market.

“Rochester’s double-digit growth product portfolio, including their customer access programs, is a key building block in our strategy to access faster growing markets over the long-term,” Bard Chairman and CEO Timothy Ring said in a statement. “We believe that strengthening our position in the home care market, and specifically the large and fast-growing intermittent self-catheter segment, is strategically important at this time.”

By 2018, an estimated 1.1 billion individuals worldwide will be affected by some form of lower urinary tract or bladder outlet obstruction, Bard said. Urinary retention and incontinence are common chronic conditions with these patients that require products outside the hospital.

Abbott to shell out $560M for eye surgery, stent companies

July 15, 2013 | By Damian Garde

Abbott Labs will acquire a laser cataract surgery system in its $250 million deal for OptiMedica.–Courtesy of OptiMedica
Sick of the slump in its medical devices segment, Abbott Laboratories ($ABT) has signed two deals to boost its med tech market share, agreeing to trade more than half a billion dollars for a maker of cataract laser surgery devices and a stent developer.

Abbott will pay $310 million for IDEV Technologies, maker of a CE marked, self-expanding nitinol stent to treat peripheral artery disease (PAD). Separately, Abbott has signed on to acquire OptiMedica for $250 million up front and up to $150 million in milestones, marking the company’s entrance to laser-assisted cataract surgery market. The deals are expected to close by year’s end.

First, IDEV: The Texas company has developed SUPERA Veritas, a stent designed to mimic the body’s natural function while propping open vessels in the thigh and knee and alleviating PAD. The device is in the midst of an FDA review, Abbott said, using data from studies on more than 1,500 patients around the world.

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FDA 510k Clearance of the MVP.

Reverse Medical Corp. officials announced FDA clearance for U.S. commercialization of the MVP Micro Vascular Plug system for peripheral artery embolization, and the first U.S. clinical cases. The MVP system indication for use is to obstruct or reduce the rate of blood flow in the peripheral vasculature.

“Our first case with the MVP-3 was impressive, and resulted in immediate vessel occlusion, which decreased procedure time. The device tracked easily through tortuous anatomy and was successfully retracted and recaptured prior to final deployment, allowing for more precise control than conventional coils,” states Ripal Gandhi, MD, Miami Baptist Cardiac and Vascular Institute.

James Benenati, MD, Medical Director, Miami Baptist Cardiac and Vascular Institute, adds, “The Microcatheter deliverability of the MVP and the opportunity to quickly occlude a vessel with one device positions the MVP as an important addition to our embolic armamentarium.”

Reverse Medical President and CEO Jeffrey Valko comments, “The MVP system represents a platform technology with broad clinical utility for Peripheral and eventual Neurovascular indications. I’m very enthusiastic about our timing with this technology, as the Embolization market is poised for dramatic growth. We forecast more than 75,000 annual procedures in the US alone. Additionally, following European CE-Mark approval, we have completed the MVP system clinical evaluation study with profound clinical success and are beginning commercialization.”

St. Jude Medical Receives European Approval for New Renal Denervation System

St. Jude Medical Receives European Approval for New Renal Denervation System That Reduces Total Ablation Time by More Than 80 Percent

August 29, 2013
Next-generation EnligHTN system for treating hypertension reduces total ablation time from approximately 24 minutes to four minutes

2013 European Society of Cardiology
ST. PAUL, Minn.–St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced the CE Mark approval of its next-generation EnligHTNâ„¢ Renal Denervation System for treating patients with drug-resistant, uncontrolled hypertension. The system features an advanced generator that delivers simultaneous ablations via a multi-electrode catheter, reducing total ablation time with the new EnligHTN system by more than 80 percent in comparison to the first generation system, from approximately 24 minutes to four minutes. The EnligHTN system will be on display during the 2013 European Society of Cardiology (ESC) meeting from August 31 to September 3.

“The new EnligHTN system improves the procedure by significantly reducing ablation time and providing optimized ablation monitoring feedback,” said Thomas Lüscher, professor and chairman of Cardiology, at the Cardiovascular Center at the University Hospital in Zurich and editor in chief of the European Heart Journal. “Renal denervation is a relatively simple, minimally-invasive procedure that is emerging as an important new avenue for managing hypertensive patients who do not respond to medications.”

Renal denervation is a catheter-based ablation procedure used to treat patients with drug-resistant hypertension (high blood pressure). The EnligHTN system delivers radiofrequency (RF) energy from an ablation catheter to create lesions (tiny scars) along the renal nerves – a network of nerves in the walls of the renal arteries thought to help control blood pressure. The intentional disruption of the nerve supply has been clinically found to help reduce systolic and diastolic blood pressure. The system catheter has a unique, non-occlusive basket design, helping physicians deliver a predictable treatment pattern while allowing for continuous blood flow to the kidney throughout the procedure.

Blood pressure reduction is quickly achieved by simultaneously administering 60 second ablations from all four catheter electrodes, which is typically performed two times in each renal artery. The advanced generator also has an icon-based touch screen interface that allows physicians to easily view and record procedure information.

“The next generation EnligHTN system offers physicians our proven multi-electrode catheter with a new intuitive, faster generator that quickly and effectively delivers consistent ablations with a significant reduction in procedure time,” said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. “These advancements deliver on our strategy to bring new innovations to a developing market to provide options for patients who currently do not have an adequate treatment for their uncontrolled drug-resistant hypertension.”

Renal denervation represents an important area of research. St. Jude Medical is conducting five renal denervation studies including the EnligHTNment landmark trial. This study is the first large-scale trial that will examine the long-term effects of renal denervation to see if the therapy also reduces the risk of heart attack, stroke, heart failure requiring hospitalization, as well as cardiovascular death in patients with uncontrolled hypertension.

The next-generation EnligHTN system is currently being evaluated in the EnligHTN III study, an international, non-randomized clinical trial that will enroll up to 50 patients in Australia and New Zealand. This study expands on EnligHTN I trial research of the first generation EnligHTN system, which demonstrated that patients with drug-resistant hypertension had a safe, rapid and sustained drop in blood pressure. After thirty days, systolic blood pressure was reduced by an average of 28 mmHg (millimeters of mercury) that remained stable with a reduction of 27 mmHg points one year after treatment.

About Hypertension

A normal blood pressure is typically at or below 120 systolic and 80 diastolic, expressed as 120/80 mmHg. Hypertension is categorized as a blood pressure reading greater than 140/90 mmHg. Lowering hypertension is important as the risk of cardiovascular death doubles with every 20 point increase in systolic blood pressure.

Hypertension or “high blood pressure” is a common medical condition that can cause life-threatening health problems such as heart disease, stroke or kidney failure that affects one in three adults worldwide according to the World Health Organization (WHO). Known as the “silent killer,” high blood pressure often presents no warning signs or symptoms and many people do not realize they have it. Drug-resistant hypertension is a condition that cannot be controlled through medication. There are more than 100 million people worldwide that are treatment resistant where at least three high blood pressure drugs do not work. The annual global health care expenditure directly related to hypertension is estimated at almost 385 billion Euros every year.

Recently, the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) issued guidelines recommending the use of catheter-based renal denervation for the treatment of high blood pressure in patients with difficult-to-treat, drug-resistant hypertension.

To learn more about renal denervation or see a demo of the next-generation EnligHTN Renal Denervation System, ESC attendees can visit St. Jude Medical at booth C310 of Exhibition Hall 1.

In 2012, the first-generation EnligHTN Renal Denervation System earned European CE Mark approval and was launched in several markets. The EnligHTN systems are not approved for use in the U.S.

About St. Jude Medical

St. Jude Medical is a global medical device manufacturer dedicated to transforming the treatment of some of the world’s most expensive, epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul Minn., St. Jude Medical has four major clinical focus areas that include cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation. For more information, please visit sjm.com.

Read more: St. Jude Medical Receives European Approval for New Renal Denervation System That Reduces Total Ablation Time by More Than 80 Percent – FierceMedicalDevices http://www.fiercemedicaldevices.com/press-releases/st-jude-medical-receives-european-approval-new-renal-denervation-system-red#ixzz2dPIwPX6r
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