Medical Device Dailys
Pérouse Laboratories (Ivry Le Temple, France) merged the operations of Sedat SA (Irigny, France) and Flashmed SA (Echternach, Luxembourg) into a new company called Pérouse Medical, based in Ivry Le Temple.
The consolidation joins product development, manufacturing and distribution activities in four categories of medical devices including cardiovascular surgery, oncology, and interventional imaging as well as subcontract manufacturing for drug delivery systems.
"In uniting these complementary expertises, we'll accelerate our performance and will reach beyond our fields to become a transversal actor of medical technologies" said President Eric Pérouse, adding that his ambition extends to projecting the new company into "the tight group of world leaders in this field."
He said he expected the united industrial group will double sales revenues over the next four years to €60 million ($83.5 million).
Perouse said the merger marks a critical stage in the development of the company that will see the exit of its original investors this year.
In 2007 a division manufacturing silicone gel breast implants, Perouse Plastie (Bornel France), was sold to the American aesthetics company Mentor (Santa Barbara, California), raising €42 million, valued at $56 million at that time, a deal that included paying off €13 million in debt ($17.5 million) (Medical Device Daily, June 29, 2007).
The new combined company has 295 employees and said it invests in excess of 15% of sales revenue in research and development annually.
In cardiovascular, the Pérouse group supplies knitted polyester vascular prostheses, balloon catheters, carotid shunts, vein strippers and thoracic drainage tubing.
In oncology, the group manufacturers implantable catheter ports and connecting tubes with needles.
For interventional imaging, Pérouse supplies three-way stopcocks, connectors, inflation devices and control syringes for angiography.
Lap-Band system seen aiding diabetes fight
Allergan (Irvine, California) said its Lap-Band AP System for obesity intervention has become the first device to receive official European approval for weight loss that leads to improvement or remission of Type 2 diabetes.
Type 2 diabetes has reached pandemic proportions, and the risk of developing Type 2 diabetes is increased up to 10 times in people who are obese. Obesity is defined as having a Body Mass Index of 30 or greater.
The UK has the fastest-growing rate of obesity in the developed world, with the number of obese people with Type 2 diabetes estimated to have increased by 1 million over the past five years.
Allergan said recent estimates are that 10% of all National Health Service (NHS) spending goes on diabetes. This equates to £9 billion a year.
"Type 2 diabetes is becoming an increasing problem as the prevalence of severe or morbid obesity in the population rises," said Dr. Jonathan Pinkney, consultant senior lecturer and diabetologist.
"The proven success of gastric banding procedures in these patients is timely and provides us with a powerful alternative to tackle the morbidity and mortality associated with diabesity," he said. Diabesity is a term coined by Shape Up America to define the correlation between diabetes and obesity.
Pinkney added, "The gastric banding procedure is a highly effective option for selected obese patients who are failing to reduce their weight through traditional weight-reduction methods. The recognition of a device such as the Lap-Band AP System by European health authorities is an important advance for the medical community and obese patients in our efforts to effectively manage Type 2 diabetes."
Positive trial results for Micro-pump
CircuLite (Saddle Brook, New Jersey) reported the publication of positive data from its ongoing CE-mark clinical trial for the Synergy Pocket Micro-pump for chronic heart failure in the Journal of the American College of Cardiology.
The company data demonstrated that partial circulatory support with Synergy yielded statistically significant long-term improvements in cardiac function, hemodynamic benefits and evidence of myocardial recovery. These results were originally presented in a late-breaking session at the 2009 annual meeting of the American College of Cardiology (Washington). Synergy is a micro-blood pump, the size of an AA battery, that can be implanted superficially in a "pacemaker-like" pocket. Synergy is the first and smallest device designed for partial circulatory support (up to 3L/min) and long-term use in patients with Class IIIb and early Class IV heart failure.
Senior author Daniel Burkhoff, MD, PhD, chief medical officer of CircuLite and adjunct associate professor of medicine at Columbia University Medical School (New York), noted: "Data from the ongoing CE-mark trial continue to show that Synergy provides significant hemodynamic benefits to patients and prevents progressive hemodynamic deterioration. Synergy, with its small size and minimally invasive procedure, could result in quality-of-life improvements for patients CircuLite's ultimate goal for this device."
President/CEO Paul Southworth added, "This publication provides another layer of scientific validation for the Synergy device and human proof-of-concept for its unique approach of providing long-term, partial circulatory support. We believe that Synergy offers a less-invasive alternative to full-support LVADs, expanding the potential population who could benefit from circulatory support devices to those patients with less-advanced disease who are hemodynamically compromised but are also not optimally addressed by current device- and drug-based therapies."
He said the company anticipates receipt of the CE mark and launch of the device in Europe later this year.