Staff Report

Sunshine Heart (Eden Prairie, Minnesota) said the company's initial Austrian site for the OPTIONS-HF study has implanted its first patient with the C-Pulse System for moderate to severe heart failure. Herwig Antretter of the University of Innsbruck performed the operation, which took place on November 11th, 2014. A 92 minute surgical implantation procedure was completed and the patient was discharged from the hospital 7 days post-surgery. This milestone marks the eleventh implantation of the C-Pulse System across fourteen activated EU centers participating in the OPTIONS HF post-market surveillance clinical study.

"The C-pulse system is an ideal addition for patients in the treatment of NYHA III and ambulatory IV stage heart failure," said Antretter. "It is easy to implant the device, doesn't need a heart lung machine, and allows for quick patient recovery. Our patient was extubated in the operating room, stayed just a couple of hours in the ICU, and was then transferred to a normal ward. We discharged him after only one week."

The OPTIONS HF study is a post-market, multi-center, prospective, open label study that will include 50 patients in up to 15 European centers. The study is designed to observe clinical outcomes of heart failure patients treated with the C-Pulse system. The primary endpoint is comparable to the COUNTER HF trial as it evaluates the rate of re-hospitalization due to worsening heart failure and heart failure related death in addition to many other traditional heart failure endpoints.

The C-Pulse Heart Assist System, or C-Pulse System, an investigational device in the U.S., Canada and countries that do not recognize the CE mark approval, uses the scientific principles of intra-aortic balloon counterpulsation applied in an extra-aortic approach to assist the left ventricle by reducing the workload required to pump blood throughout the body, while increasing blood flow to the coronary arteries. Combined, these potential benefits may help sustain the patient's current condition or, in some cases, reverse the heart failure process, thereby potentially preventing the need for later-stage heart failure devices, such as left ventricular assist devices, artificial hearts or transplants.

Cardiovascular Systems completes Japanese enrollment

Cardiovascular Systems (St. Paul, Minnesota) has completed enrollment in Japan for its Coronary Orbital Atherectomy System Trial (COAST) study. Taking place in both Japan and the United States, the study is designed to assess the safety and efficacy, as well as economic outcomes, of CSI's new investigational micro crown Orbital Atherectomy System (OAS) in treating severely calcified coronary lesions in patients suffering from Coronary Artery Disease (CAD).

COAST requires a minimum of 50 patients in the U.S. at up to 15 sites and a minimum of 25 patients across five sites in Japan for a total of 100 patients to be enrolled. CSI surpassed its required number of enrollments in Japan with a total of 26 patients on Nov. 20, 2014. Enrollment in the U.S. is expected to be completed in 2015.

The 1.25 mm micro crown is CSI's second-generation system designed to facilitate stent delivery in patients with severely calcified lesions who are acceptable candidates for percutaneous transluminal coronary angioplasty (PTCA) or stenting. The micro crown OAS is designed to improve the tracking and piloting of the OAS driveshaft and the ability of the crown to reach the lesion while operating at lower rotational speeds.

COAST builds on CSI's ORBIT II study, the first trial designed to study patients with severely calcified lesions who are typically excluded from all major trials but commonly seen in the real world. It is a prospective, single-arm, multi-center, global, investigational study.

Cardiovascular Systems is developing solutions for treating vascular and coronary disease.

Biolight gets first sale in Poland

BioLight Life Sciences Investments (Tel Aviv, Israel), a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, reported the first sale of an IOPtiMat system to a medical center located in Poland following a successful product trial.

The sale of this first system in Poland is the result of the an intensive marketing campaign to leading physicians and medical centers mainly in Asia and also in other selected territories for the IOPtiMate system as part of the company's focus on markets with unmet needs for better solutions to treat glaucoma.

"We are pleased that this medical center selected the IOPtiMate system as its glaucoma surgery solution. This milestone conveys further confidence in our unique technology from the ophthalmology community and, along with our recent first sale in Hong Kong and our launch in China, demonstrates our ability to become a truly global player in this marketplace," said Suzana Nahum-Zilberberg, BioLight's CEO.

The IOPtiMate system is based on CO2 laser technology that enables the performance of a unique filtration surgery to treat glaucoma without penetrating the inner part of the eyeball, thus allowing for substantial reductions in post-operative complications and use of eye drops compared with alternatives.

BioLight Life Sciences Investments invests in, manages and commercializes biomedical innovations grouped around defined medical conditions – ophthalmology and cancer diagnostics.

Accovion establishes subsidiary in France

Accovion (Frankfurt, Germany), an independent European full-service Contract Research Organization, reported the establishement of a new subsidiary in Lyon, France, as it continues its expansion across Europe. Together with offices in Italy, Poland, Russia, Romania, Spain, Czech Republic and United Kingdom, Accovion is now able to present itself with eight subsidiaries and overall coverage of 20 European countries.

Ivana Waller, the COO of Accovion Group, said "France represents a key strategic territory in terms of conducting clinical trials in Europe and therefore the new French subsidiary reinforces our mission to better serve our clients by offering a broader European footprint. The rationale for setting up the company specifically in Lyon is based on the fact that this region has a high concentration of pharmaceutical and biotech companies, as well as various related support companies engaged in the field of life sciences. This provides us with proximity to our clients, access to experienced talent pool, abundant clinical research sites as well as access to key opinion leaders." She adds: "The city of Lyon provides an active support to the life sciences companies, including many networking opportunities and rigorous support and promotion of the local Bio-cluster. In addition, the city is generally business friendly and progressive."

The local entity will be headed by Olivier Humbey, who was appointed Country Director, France on Nov. 1. Humbey will be spearheading not only the company's activities in France, but given his extensive scientific background, well-networked position in the industry and abundant experience, strongly support the strategies of the entire Accovion Group.

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