A Medical Device Daily

Cordis (Miami Lakes, Florida), a Johnson & Johnson (New Brunswick, New Jersey) company, reported the European launch of its next generation of bare metal stent system Presillion Plus. The new stent system, which improves upon the Presillion, features important technological advances designed to gain easier access to distal lesions and help restore the artery's natural form, the company said.

“The new upgraded delivery system increases the speed of procedures with atraumatic delivery, increased pushability, and smoother withdrawal. We are very satisfied with the speed in which we were able to incorporate feedback from cardiologists into the new design,“ said Campbell Rogers MD, global head of R&D of Cordis.

The system changes include a new hypotube for improved pushability in crossing calcified lesions and a redesigned semi-compliant balloon for precise stent deployment and decreased deflation time.

The stent is available in lengths from 8 mm to 33 mm including a new 28 mm addition and in diameters from 2.5 mm to 4.0 mm.

The PIONIR study, designed to measure the safety and effectiveness of Presillion and Presillion Plus, has completed enrollment at 16 sites in Europe and Israel. The study, conducted by Medinol (Jerusalem), includes 278 patients and will evaluate clinical performance through one year.

Cordis is the exclusive global distributor of Presillion Plus, which is designed and manufactured by Medinol.

Veryan secures additional $5.4 million

Veryan (London) reported that it has secured additional funding totaling £3.6 million ($5.4 million) from a syndicate of investors led by new investor Seroba Kernel, a European life science venture capital firm, alongside existing investors Imperial Innovations, Oxford Capital Partners Limited and NESTA. The funds will be employed to finance further development activities and a pivotal clinical trial designed to show the clinical benefit of Veryans' unique BioMimics 3-D stent technology.

Veryan is developing a novel stent platform technology that imposes a 3-D helical geometry onto the stented vessel segment which generates physiological swirling blood flow and has been shown to significantly reduce restenosis (re-narrowing) in pre-clinical experiments. In addition, Veryan has established that the 3-D geometry confers significant mechanical benefits. The company said the BioMimics 3-D stents are more flexible, kink-resistant and fracture resistant than traditional stents. The Veryan concept was originally conceived by Professor Colin Caro at Imperial College (London).

Initially targeted at peripheral vessels, the BioMimics 3-D technology is also being developed for all vascular stent applications, this will allow the company to target entry into the total stent market.

The company recently commenced a first-in-man and CE mark study at Herz Zentrum (Bad Krozingen, Germany). As well as providing supporting data for achievement of CE mark status, this study will evaluate the clinical performance attributes of the BioMimics 3-D technology against a contemporary control stent and will include the assessment of a number of differentiating features of the Veryan stent technology.

biospace med enters Benelux distribution deal

biospace med (Paris) an emerging medical technology company based in Paris, and Oldelft Benelux (Utrecht, the Netherlands), a specialist in medical diagnostic imaging, reported the signature of an exclusive distribution agreement of EOS, the world's first ultra-low-dose 2-D/3-D imager. The agreement will cover the distribution of EOS for the Benelux area (Belgium, the Netherlands and Luxembourg).

“The installation of our ultra-low-dose EOS imager in the University Medical Center Groningen (Groningen, the Netherlands), one of the largest hospitals in the Netherlands, has clearly demonstrated the great interest of the Dutch medical community for our breakthrough technology. We are very enthusiastic about this agreement with a key player in the Benelux medical imaging field,“ said Peter Cardle, biospace med's VP of sales.

Greek hospital completes 1st TAH training phase

At the beginning of March, the surgical team from the Onassis Cardiac Surgery Center (Athens, Greece), led by Petros Sfirakis, MD, director of the transplantation department & mechanical support unit and Dr. Louis Louca, Surgeon/VAD Coordinator, completed the first phase of certification training to implant the Syncardia (Tucson, Arizona) CardioWest total artificial heart (TAH).

“Many people die waiting for a heart transplant in Greece because we have the lowest rate of organ donation in Europe,“ said Sfirakis. “The total artificial heart can save the lives of patients with end-stage biventricular failure and improve their overall health so they are in better condition for their heart transplant.“

Greece has an annual rate of only seven donors per million population.

The Onassis Cardiac Surgery Center is the first hospital in Greece and the 51st in the world to complete the first phase of certification training. To become a SynCardia Certified Center, hospitals must apply for and complete a rigorous, four-phase training program, including the first proctored implant by an experienced TAH surgeon.

There have been more than 800 implants of the TAH, accounting for more than 180 patient years of life on the device. Originally used as a permanent replacement heart, the TAH is currently approved as a bridge to human heart transplant for people dying from end-stage biventricular failure. The Total Artificial Heart is the only device that provides immediate, safe blood flow of up to 9.5 L/min through both ventricles.