A Medical Device Daily

Boston Scientific (Natick, Massachusetts) has received CE-mark approval of its Confient implantable cardioverter-defibrillator (ICD), the first Boston Scientific-branded cardiac rhythm management device to treat sudden cardiac death (SCD).

The new ICD, which the company said includes “an enhanced AV Search Hysteresis feature,” is designed to reduce unnecessary right ventricular pacing.

It said the device “also contains wireless capability that is designed to save physicians time during implant by allowing device programming during wound closure while also eliminating the need for the wand in the sterile field.”

The company said it also saves time at follow-up with device interrogations that can be three times faster than Boston Sci’s wanded telemetry.

“The Confient ICD is an example of our Cardiac Rhythm Management group’s ability to deliver meaningful product innovation,” said president/CEO Jim Tobin. “We look forward to making this ICD broadly available to physicians so they can offer this advanced therapy to patients who are at risk of sudden cardiac death.”

Boston Scientific said that sudden cardiac death claims the lives of as many as 350,000 people in Europe each year. “More people die from sudden cardiac death each year than from lung cancer, breast cancer and AIDS combined,” the company said.

The Confient device is not approved for sale in the U.S.

Reimbursement approval for Spectranetics

Spectranetics (Colorado Springs, Colorado) said it has received reimbursement approval in Belgium for its lead removal and peripheral atherectomy product line.

The company said the reimbursement for the lead removal indication — an embedded, infected lead or an electronic malfunction of a pacemaker or defibrillator electrode — applies to hospitals in Belgium that meet national cardiac pathology requirements and standards.

It said the reimbursement for the peripheral indication applies to all centers in Belgium equipped with Spectranetics’ technology for patients that suffer from critical limb ischemia with non-healing ulcers or rest pain due to infra-popliteal disease.

Shar Matin, managing director of Spectranetics International, said, “Belgian patients now have greater access to our life-changing technology. Reimbursement initiatives are a cornerstone of Spectranetics International’s strategy and this approval follows the reimbursement approval in Germany for our peripheral atherectomy device earlier this year.”

Spectranetics manufactures the only excimer laser approved in the U.S., Europe and Japan for use in minimally invasive cardiovascular procedures. “The device treats complex cardiovascular conditions by photo-ablating multiple lesion types into tiny particles that are easily absorbed into the blood stream,” the company said. Its disposable catheters use high-energy, “cool” ultraviolet light to vaporize arterial blockages in the legs and heart, as well as scar tissue encapsulating pacing and defibrillation leads.

Spectranetics also reported recently that it has enrolled the first patient in the PATENT trial utilizing the company’s Turbo elite laser catheters in combination with the recently FDA-cleared Turbo-Booster.

The PATENT trial is a prospective registry of 100 patients at up to 10 sites in Germany. The trial will assess patency as measured by duplex ultrasound at various intervals up to 12 months following the procedure. It also will assess safety as measured by adverse events up to 12 months following the procedure.

In the initial procedure performed at the University of Leipzig Heart Center, four focal lesions were treated successfully with the Turbo-Booster and Turbo elite 2.0 mm catheter in a 20 cm-long stented superficial femoral artery.

“The initial result from this Spectranetics device looks very promising, as the new features allow for ablation of more tissue in larger vessels,” said Andrej Schmidt, MD, of the Leipzig Heart Center. “In-stent restenosis in a superficial femoral artery represents one of the most challenging procedures in our practice. The current standard of care, such as repeat balloon angioplasty, does not have good results as these lesions tend to reoccur.”

He added, “We are excited with the start of this study in Germany, and we look forward to examining the mid- and long-term results of this new therapy.”

Parexel broadens its GMP capabilities

Parexel Consulting, a business unit of Parexel International (Boston), reported that it is strengthening its Good Manufacturing Practice (GMP) capabilities in Europe to help its global client base address the complexities of European Union (EU) directives in areas such as manufacturing regulations, quality and safety.

Parexel is a global life sciences consultancy serving the biopharmaceutical and medical device industries.

The new initiative includes the addition of three senior consultants to the Parexel Consulting team based in Europe. Clive Brading, formerly in a senior corporate quality assurance role at Sanofi-Aventis, has been named director to lead the company’s European team focused on strategic compliance and operational process excellence.

Dr. Ralf Hess, who served as chief scientific officer for HISS Diagnostics, and Dr. Siegfried Schmitt, previously a global quality assurance director for Amersham Health (now GE Healthcare), have both been appointed to the post of principal consultant.

“As companies face intensifying safety obligations, rising operational costs, and the complexities of EU regulations and ICH quality guidelines, they need help to proactively and effectively manage these hurdles,” said Gadi Saarony, corporate vice president and worldwide head of Parexel Consulting.

Casazza heads SpineVision’s business in Italy

Vittorio Casazza has been named general manager of SpineVision’s (Paris) subsidiary in Italy. Casazza previously was with Wright Medical Italy since 2004 as business director, in charge of the overall operations of the company. Earlier in his career, he held executive positions with Medtronic Sofamor Danek Italy and with PriceWaterHouseCoopers in Italy.

“We are committed to growing our presence throughout Europe, and certainly Italy is one of the key countries in our success blueprint,” said SpineVision CEO Julian Mackenzie. “Casazza’s proven track record in implementing transformation ... makes him the ideal executive to secure a broad base of support and buy-in of our expansion plans across all levels and functions of our Italian subsidiary.”