A Medical Device Daily

Invatec (Roncadelle, Italy), a developer of interventional products, reported CE-mark certification of a new coronary balloon, the IN.PACT Falcon paclitaxel-eluting PTCA balloon catheter.

The company said this is one of the first drug-eluting balloons designed specifically to treat atherosclerosis in the coronary arteries.

IN.PACT Falcon features FreePac, a proprietary, natural coating that frees and separates paclitaxel molecules and facilitates their absorption into the wall of the artery. The FreePac coating was developed in collaboration with the German researchers who pioneered drug-eluting balloon therapy, Ulrich Speck and Bruno Scheller, PhD.

"We are ... excited to commercialize a much-needed product that combines our FreePac coating technology with the performance-leading characteristics of our Falcon PTCA balloon platform, thereby creating a world-class drug-eluting balloon," said Andrea Venturelli and Stefan Widensohler, co-founders of Invatec.

They added: "The European availability of IN.PACT Falcon underscores our mission to provide physicians with the option of using drug-eluting balloons for specific clinical indications throughout the coronary and peripheral anatomy. The launch of IN.PACT Falcon ... aligns with our strategy to leverage FreePac on all of our major balloon platforms."

In a statement, Scheller and Speck said: "The drug-eluting balloon concept has already shown its potential to reduce re-intervention rates for patients with coronary atherosclerosis in clinical trials in a selected patient population. Therefore the launch of efficacious matrix coatings on modern coronary balloon catheters ... is a major milestone in the development of appropriate ways to treat coronary atherosclerosis."

Noted cardiologist Eberhard Grube, MD, of Heart Center Siegburg in Germany, commented, "Combining world-class PTCA balloon catheter technology with local drug administration is a fascinating new concept for the treatment of certain coronary lesions such as in-stent restenosis, bifurcations, small-vessel disease and potentially other lesions where conventional balloons, stents and even drug-eluting stents may not be ideal. A drug-eluting balloon such as the IN.PACT Falcon that elutes a known and effective drug such as paclitaxel holds much promise as an effective treatment option for patients."

In addition to the IN.PACT Falcon paclitaxel-eluting balloon, Invatec recently launched IN.PACT Amphirion, its first drug-eluting balloon designed specifically for the treatment of atherosclerosis in arteries located below the knee.

Invatec was founded in 1996 and has grown to almost 1,000 employees worldwide. Its U.S. headquarters is in Bethlehem, Pennsylvania.

New urethral stent introduced

Allium Group (Caesarea, Israel), a maker of stents for the urinary, gastrointestinal, pulmonary and peripheral vascular tracts, said that its CE-marked Urethral Bulbar Stent will now be accessible to patients in Europe.

The company said the stent offers a "viable solution" to urologists who are not experts in urethral reconstructive surgery, who now can treat patients with recurrent strictures by inserting the urethral bulbar stent in an office-based, outpatient procedure.

Allium said European distribution of the stent "will enable patients to select a minimally invasive procedure to manage their recurring stricture."

The Bulbar Urethral Stent is the latest in a line of stent products the company has launched in Europe.

CEO Limor Domnitz Gishri said, "Stents have emerged as a therapeutic tool to treat patients with obstructions and strictures given its minimally invasive characteristics. With [our] Bulbar Urethral Stent now available to the wider European medical community, more patients will have the option to forego repeated dilating procedures or surgery for a simple procedure which will enable the attainment of a greater quality of life."

The Bulbar Urethral Stent is a large-caliber, removable stent designed to fit the dimensions of the normal anatomy and function of the male bulbar urethra. Its "super elastic" skeleton allows comfort to the patient, Allium said, specifically when sitting on hard surfaces, without compromising its shape to keep the stented urethra open.

European project uses ANSYS software

Clinicians will soon have a better understanding of how to manage cerebral aneurysms, thanks to a European project that uses simulation software from ANSYS (Canonsburg, Pennsylvania).

The @neurIST project is an initiative that seeks to integrate biomedical informatics in the management of cerebral aneurysms. It has combined simulation software and a series of linked tools called a "toolchain" to provide individualized aneurysm rupture predictions.

The toolchain combines diverse, independent tools into an integrated suite, in which the output of one tool becomes the input for the next. ANSYS said the resulting automated workflow "brings together multiple strands of patient data including CT scans, X-rays, angiograms and other routine test results transforming them into 3-D representations that are the basis for dynamic simulations."

ANSYS President/CEO Jim Cashman said. "@neurIST ... fuses diagnostic, modeling and simulation data into a coherent representation of a patient's condition."

Project partners are collecting and analyzing clinical data in expectation of developing best practices and, perhaps, identifying the underlying causes of the condition.

"The aim of the @neurIST project is to transform the management of the condition by providing new insight, personalized risk assessment and methods for the design of improved medical devices and enhanced treatment protocols," said Alejandro Frangi of Universitat Pompeu Fabra (Barcelona, Spain), which is coordinating the @neurIST project.

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