A Medical Device Daily

CircuLite (Hackensack, New Jersey) reported preliminary top-line results of a pilot first-in-man study of four patients who have been implanted with the Synergy Pocket Circulatory Assist Device.

Synergy is a micro-implantable blood pump, the size of an AA battery, that can be implanted superficially in what the company describes as a "pacemaker-like" pocket. The device is designed to provide long-term, partial circulatory support in patients with chronic heart failure.

The pilot study was initiated last June, evaluating Synergy in individuals awaiting a heart transplant. All four patients reached the primary endpoint of successful heart transplantation, with one patient supported for seven months.

Final data from the study will be presented at a future medical meeting.

"Patients implanted with Synergy thus far have demonstrated significant clinical improvements in hemodynamics and, importantly, quality of life," said Bart Meyns, MD, PhD, professor and chief of cardiac surgery at Gasthuisberg University Hospital (Leuven, Belgium). "This system was designed to improve the quality of life of chronic heart failure patients by giving them a less-invasive option to increase blood flow from the heart, so we are encouraged to see that initial patient experiences have been consistent with this goal."

"Having completed enrollment completed in the short-term pilot study, CircuLite President/CEO Paul Southworth said the company now is focused on "evaluating Synergy for long-term use in patients who remain symptomatic despite optimal medical management, but may also not be sick enough to be eligible for one of the few donor hearts available each year."

"This large, underserved population of over 2 million patients is the ultimate target for our device," he said. "We believe that long-term, partial circulatory assist represents a new and promising treatment approach to chronic heart failure that may better address these patients, and we are excited by the significant impact on hemodynamics and quality of life experienced in the pilot study patients."

The pilot study cohort will be included in CircuLite's 20-patient long-term support CE-mark trial that is currently enrolling patients. The trial is designed to support a CE-mark filing at the end of 2008.

The key component of the Synergy device is the micro-pump technology acquired by the company after eight years of development at the Helmholtz Institute (Aachen, Germany), which CircuLite characterized as "one of the world's leading centers for blood pump technology development."

Scandinavian distribution for Allium stents

Allium Medical Group (Caesarea, Israel), a manufacturer of large-caliber, removable, non-vascular stents, said it has entered into an exclusive distribution agreement with SynMed Medicinteknik (Stockholm, Sweden) for Allium's biliary and ureteral stents in the Swedish and Scandinavian markets.

SynMed Medicinteknik is part of the SynMed International Distributor Network, consisting of several European independent distributors of medical diagnostic equipment covering areas of gastroenterology, urology and neurodiagnostics.

Per Gezelius, general manager of SynMed Medicinteknik, said, "Our initial agreement with Allium Medical was to distribute the biliary stent in Sweden. The feedback we received from both doctors and patients at medical centers in Stockholm and Helsinki was so strongly positive that we decided to expand our offering to include the ureteral stent, and requested exclusive distribution rights not only for Sweden but for all Scandinavia."

Allium Group, which was founded in 2001, has developed site-specific, large-caliber dynamic stents for various uses with applications in the urinary and gastro-intestinal tract. Allium completed CE marking for its biliary and ureteral stents, and began distribution of its biliary stents as of June 2007 in Italy, Sweden, Germany and Austria.

The two different deployment devices of the Allium's biliary stents allow endoscopic (by gastroenterologists) or percutaneous trans-hepatic (by interventional radiologists) insertion. Its ureteral stents are mounted on two different deployment devices allowing endoscopic retrograde (by urologists), or percutaneous antegrade, or combined antegrade and retrograde insertion (with or without an interventional radiologist).

"We are developing a whole new approach to stenting," said Daniel Yachia, MD, founder, president and chief scientific officer of the Allium Group. "Our technology platform allows us to create dynamic stents that are anatomically and functionally compatible, with minimal to no interference with host organ function."

Yachia added, "Now more than ever, doctors are seeking solutions to meet demand for minimally invasive solutions to increase patient comfort and convenience while not compromising on treatment efficacy. Our technology allows us to create site-specific stents so that every organ has an easily removable stent of its own."

UK firm acquires Prodesco, Secant Medical

Prodesco (Perkaskie, Pennsylvania), a designer and manufacturer of engineered textile structures for industries ranging from aerospace to industrial and medical, said earlier this month that its board had agreed to the company's acquisition by Fenner (Yorkshire, UK), which it termed "a worldwide leader in reinforced polymer engineering."

The UK firm's products include conveyor belts for the mining and power generation markets, precision motion control products for the computer, copier and mechanical equipment markets, and sealing products for the mining, hydraulics, and oil and gas industries.

The purchase included all outstanding shares of Prodesco and its wholly-owned subsidiary in the medical fabrics market, Secant Medical (also Perkaskie).

Nick Hobson, managing director of Fenner's Precision Polymer Division, said the acquisition was a "logical extension" of Fenner's core expertise in textile engineering: "Both Fenner and Prodesco have strong and long-standing reputations in specialized technical markets," he said. "We look forward to welcoming Prodesco, its employees, and its customers into our worldwide company."

Both Prodesco and Secant Medical will continue to operate with current staff and leadership from existing facilities in Perkasie. No employee reductions or facility consolidations are anticipated.

Fenner has additional locations in the U.S., including production facilities in Manheim, Pennsylvania, located less than two hours from Prodesco's offices.