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 cardiovascular, the Pérouse group supplies knitted polyester vascular prostheses, balloon catheters, carotid shunts, vein strippers and thoracic drainage tubing.
Explosive growth in Europe for Edwards
Edwards Lifesciences (Irvine, California) has opened a new European headquarters in Nyon, Switzerland, to serve the company's growing Europe, Middle East and Africa (EMEA) operations.
On the edge of Lake Geneva, the new center supports the rapid adoption of catheter-based implantation of heart valves that saw the number of European centers practicing this less-invasive alternative to open heart surgery increased a staggering four-fold in a single year.
Even as the first clinical studies of one-year evidence of safety and effectiveness for transcatheter aortic valve implants (TAVI) were being presented, adoption by cardiac surgeons exploded.
Where Edwards supported 30 medical centers practicing TAVI in April 2008, one year later there were 125 centers using Edwards' devices. The number of implants jumped from 160 to 2,250 in the same period.
Patrick Verguet, Edwards' corporate VP for EMEA, said the new headquarters "will help us accommodate our significant regional growth in heart valves and critical care, and allow us to continue benefiting from a favorable business climate."
The company has forecast TAVI sales to double this year over 2008 reaching $100 million.
"People say there is no reward for innovation until you get to the United States, but the rapid acceptance of our products here in Europe shows a different story, and Europe is becoming a bigger piece of the Edwards' pie," CEO Mike Mussallem told CD&D.
Surgeon training in the procedure is a critical step toward greater adoption and the new Nyon center features a state-of-the-art facility where surgeon's serving as proctors teach and coach their peers in wet labs and on simulators for this delicate procedure that is indicated only for patients, typically older than 75, who are denied open-heart surgery due to co-morbidities and fragile health.
The Europe center is also expected to play a pivotal role in the roll out and continuing development of new Edwards technologies that significantly include a transfermoral delivery system for a new valve the Sapien XT.
Positive CE mark 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 a 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.
Siemens sales 500th dual-source CT system
Siemens Healthcare (Erlangen, Germany) is celebrating the 500th installation of a Somaton dual-source computed tomography (CT) scanner that was introduced less than four years ago.
A novel feature for CT diagnostic imaging unique to Siemens, the company interprets the strong sales of dual-source scanners as proof of its acceptance and adoption by the medical community.
As major competitors in radiology have raced to expand the size of arrays of detectors to render greater detail and faster captures, Siemens bet on two X-ray tubes instead, creating different, and according to Dr. Sami Atiya, CEO of CT at Siemens, superior images.
Half the size and significantly lighter than conventional tubes, the company's Straton tube made it possible to arrange two X-ray tube assemblies and two detectors in the gantry.
Doubling the speed of a scan with dual-source CT enabled the Somaton units to capture a highly detailed image of a heart, literally, in a heartbeat, during the diastolic phase.
CorNova wins CE mark for Valecor stent
CorNova (Burlington, Massachusetts) said it has received CE-mark approval for its Valecor Platinum Coronary Stent System.
The Valecor Platinum is a next-generation cobalt-chromium bare-metal stent. Using a ion-based implantation technology called Nanofusion, the Valecor Platinum stent presents a pure platinum surface to both the lumen and artery wall to provide protection from less biocompatible components inherent in all medical-grade alloys. Platinum is known for its superior biocompatibility and biostability.
In addition, the company said its new stent offers some of the thinnest struts available and a novel open cell design that maximizes flexibility and conformability, while causing minimal inflammation and tissue damage during deployment.
"The Valecor Platinum Coronary Stent System represents a major advancement over current offerings in the relatively undifferentiated $1 billion bare stent market," said S. Eric Ryan, MD, chairman/CEO of CorNova. "Because of its highly biocompatible platinum surface and its novel open cell design, it has shown superior anti-restentotic performance compared to leading bare metal stents in preclinical studies."
Spectranetics approved for ThromCat XT
Spectranetics (Colorado Springs, Colorado) reported receiving CE-mark approval for its next-generation ThromCat XT Thrombus Removal System, a single-use, disposable device indicated for mechanical removal of thrombus from native coronary arteries and infra-inguinal arteries. The launch of the product will commence immediately within the European Union.
The approval triggers a milestone payment of $1.5 million under the company's development agreement with Kensey Nash (Exton, Pennsylvania).
The ThromCat XT System is an improvement to the current ThromCat System with enhanced thrombus removal and several advancements in ease-of-use. The ThromCat XT System generates a consistent vacuum pressure at the tip of the catheter to draw thrombus into the extraction ports where it is then macerated by an internal helix. Without further contact with the bloodstream, the thrombus is then transported to an external collection bag.
The ThromCat XT is disposable and offered in 150 cm length to treat vessels 2.5 mm to 7 mm in diameter.
First implant of Sorin's new ICD
Sorin Group (Milan, Italy), a developer of devices for the treatment of cardiovascular diseases, reported the commercial market release and first implant of its new-generation Paradym DR 8550 dual-chamber implantable cardioverter-defibrillator (ICD).
Paradym DR is the second product of a new platform with what Sorin terms "cutting-edge electrical performance," combining high-energy shocks, with an expected 9.5 years longevity in a 32.8 cc device.
Paradym can charge up to 42 Joules, and delivers the highest energy shocks on the market whenever needed to treat a life-threatening arrhythmia, according to the company.
Sorin said Paradym DR features its Parad+ detection algorithm, "providing accurate therapy based on superior specificity in discriminating supraventricular tachyarrhythmias [SVT]."
The company noted that ventricular arrhythmias often occur as regular ventricular tachycardia (VT). "In most cases, these VTs can be terminated by painless anti-tachy pacing (ATP), and a painful and stressful shock can be avoided."
It said Paradym DR is designed to detect and treat the VTs with ATP over a range of heart rates from 100 min up to 255 min.
Paradym DR also includes the SafeR function, which allows spontaneous atrio-ventricular conduction, while managing all three types of heart block (first, second and third degree). "In this way right ventricular pacing, which has been shown to increase the risk of congestive heart failure and atrial fibrillation, can be reduced to 0.1%," Sorin said.
CE mark to Medtronic for MRI-safe pacemaker
Medtronic (Minneapolis) said it has received the CE mark for its second-generation pacemaker designed for use as labeled with MRI machines, the Advisa DR MRI SureScan pacing system.
About 2 million Europeans have pacemakers implanted, but those patients are strongly discouraged from receiving MRI scans because their device could interact with MRI machines, potentially affecting the device or patient safety. According to estimates, 50% to 75% of patients worldwide with implanted cardiac devices are expected to need an MRI scan during the lifetime of their devices.
The Advisa MRI SureScan pacing system is the most advanced pacing system from Medtronic and combines for the first time MRI SureScan with key features from Medtronic pacemakers and defibrillator systems such as MVP (Managed Ventricular Pacing), OptiVol Fluid Status Monitoring, and Ventricular and Atrial Capture Management (VCM and ACM).
Upon commercial release, the Advisa MRI SureScan pacing system will be available for remote follow-up via the Medtronic CareLink Network.
1st EMS buyer for new Zoll system
Zoll Medical (Chelmsford, Massachusetts), a maker of resuscitation devices and related software solutions, said the ambulance service, RAV Gooi en Vechtstreek (Hilversum, the Netherlands), is the first EMS organization to equip its ambulances with what the company terms "a revolutionary new system" that allows rescuers to defibrillate a heart without the need to stop chest compressions.
Zoll said the real-time integrated operation of the new AutoPulse Plus and the E Series coordinates the ability to provide consistent, uninterrupted chest compressions with timed shock delivery.
Integrating these two therapeutic interventions into a seamless rescue effort has long been viewed as critical to advancing resuscitation care. Both the AutoPulse Plus and the E Series have the CE mark.
According to the company, the AutoPulse offers a "significant advantage" over manual CPR because it moves more blood, more consistently, than is possible with human hands. "AutoPulse delivers high-quality, uninterrupted chest compressions to maintain myocardial and cerebral perfusion," Zoll said. "It offers the benefit of freeing up rescuers to focus on other life-saving interventions, and keeps them safer by eliminating the need to conduct CPR while unrestrained in the back of a moving ambulance."
More than 4,000 AutoPulse units have been deployed in hospitals and emergency services worldwide.
Zoll markets and sells its products in more than 140 countries.
First implantations of Evia pacemaker in Europe
Biotronik (Berlin), a maker of wireless remote monitoring technologies and a manufacturer of implantable cardiac devices, reported CE-mark approval and first implantations of its new Evia cardiac pacemaker series, offering superior therapies and functionality in every step of advanced patient management.
After receiving the CE mark, the first Evia devices were implanted simultaneously at seven hospitals across Europe during the first week of June.
Evia pacemakers are already designed to be MRI-conditional, and Biotronik said it is planning to launch a new pacemaker-lead system which will be MRI-compatible under specific conditions during the first half of 2010.