August 2013


Study shows sustained improvement with Revivent


Myocardial Anchoring System According to results published in the European Journal of Cardio-Thoracic Surgery, 39.6% of the first 11 patients implanted with BioVentrix’s Myocardial Anchoring System had a sustained improvement in heart function at one year


A


press release reported that the patients sustained a mean reduc- tion in left ventricular end-systolic volume index to 43.9 mL/m2, which is below the 60mL/m2 threshold recently defined as providing a survival benefit in heart failure patients. BioVentrix also an- nounced that the number of heart failure centres trained to perform the LIVE pro- cedure has expanded to 20 leading centres throughout Western Europe. “The extent of volume reduction achieved, and more importantly main- tained at one year, using the Revivent System is comparable with, and in some cases exceeds, the results achieved in multiple clinical studies using a conven- tional surgical approach to reducing the volume of the left ventricle,” said Andrew S Wechsler, professor of Cardiothoracic Surgery at Drexel University College of Medicine in Philadelphia, Penn, USA. “These results demonstrate that effective volume reduction, using a less invasive


approach, provides meaningful clinical benefit to a previously untreated, fragile patient population.”


Since submission of data from the first


11-patients to EJCTS, an additional 15 patients have reached the crucial one- year survival mark. Combined these 26 patients treated with the Revivent System have maintained a mean left ventricular end-systolic volume index of 57.4mL/ m2 for one year following the procedure, which represents a mean decrease of 33.5%.


According to the press release, the Revivent System is uniquely designed to reduce wall tension by directly reducing the left ventricular radius, which in turn decreases wall tension and interrupts the ongoing destructive process of ischemic heart failure.


Phase I clinical trials, which led to the CE mark in November 2012, using the Revivent System were conducted at four European sites.


Heart failure


CircuLite receives approval for CE mark trial for Synergy IC circulatory support system


C


ircuLite has announced that it has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE mark trial of the Synergy IC circulatory support system. According to the company, it is the first mechanical support system that does not require major surgery. The Synergy system is based on the surgical Synergy system, which according to the company is the world’s smallest commercially available circulatory support pump, and is designed to treat ambulatory chronic heart failure patients (INTERMACS ≥4).


In a press release, the system was de- scribed as a superficially placed micro- pump platform surgical system, with the first implantable circulatory support sys- tem whose Inflow Cannula is designed to be implanted by a cardiologist using standard interventional techniques. The procedure is designed to further reduce the invasiveness of implantation, and thereby reduce the rate and severity of adverse events.


“Imagine being able to implant a per- manent mechanical support device in a


Meta-analysis presented at EuroPCR substantiate potential of breakthrough treatment for heart failure patients


C


ardioKinetix has recently announced the results of a meta-analysis study of the cathe- ter-based Parachute Ventricular Partitioning Device. Six-month clinical results from 91 US and European patients with ischaemic heart failure were presented at the 2013 EuroPCR in Paris, France (21–24 May) by Martyn Thomas, chairman of Car- diology at St Thomas’ Hospital in London, UK. “The results of this meta-analysis, which repre- sents the largest group of patients studied to date, are consistent with previous positive findings and continue to substantiate the Parachute treatment as a viable technology a very exciting prospect for physicians treating patients with heart failure,” said Thomas. “The Parachute promises to revolutionise the treatment for heart attack survivors whose hearts enlarge over time and subsequently suffer from heart failure symptoms, offering hope for a better quality of life for many patients.”


Clinical data from 91 patients to reach six-month follow-up has demonstrated successful delivery and deployment of the Parachute implant, without the occurrence of major adverse cardiac events related to the device, in 90% (82/91) of patients at six months following treatment. In addition, six months following treatment, 89% of patients demonstrated improved or maintained New York Heart Associa- tion (NYHA) functional class status. Specifically in the NYHA III subgroup, 27% improved two classes. The treatment also demonstrated a reduction in left ventricular volume, with a 20% reduction in end di- astolic volume and a 23% reduction in end systolic volume (p<0.001).


“The results of this meta-analysis along with Parachute


the recent completion of our post-market safety surveillance trial add to our excitement about the Parachute treatment, which we believe holds the po- tential to improve the lives of tens of thousands of patients around the world and reduce the economic burden of heart failure,” said Maria Sainz, president and CEO of CardioKinetix. “Enthusiasm about the therapy continues to grow in the clinical community in Europe, where the Parachute treatment is avail- able commercially, as well as in the USA, where the device is being studied in a landmark randomised pivotal trial.” The Parachute Ventricular Partition- ing Device received CE mark in 2011. In the USA, the Parachute system is an investigational device limited to investigational use only and is not avail- able for sale.


patient with chronic heart failure without major surgery,” said Daniel Burkhoff, chief medical officer of CircuLite and adjunct associate professor of medicine at Columbia University Medical School, USA. “If successful, this approach will usher in a new era in mechanical circulatory support, much the same way transcatheter aortic valve implantation (TAVI) did for aortic valve replace- ment.”


The multicentre CE mark trial is expected to enrol up to 20 patients, start- ing in Belgium and expanding to two additional European clinical sites. Clini- cal status, end organ function, exercise tolerance, functional capacity and qual- ity of life are intended to be assessed post-implantation. Patient screening has commenced at the University Hospi- tals Leuven, Belgium, according to the company release. “With an even less invasive, interven- tional procedure performed in the cath lab or hybrid operating room, we will be making the Synergy system more acces- sible, more convenient and potentially safer for patients,” said Paul Southworth, chief executive officer of CircuLite.


Thoratec acquires DuraHeart II ventricular


assist system T


horatec Corporation said, in a press release on 1 July, that it has acquired the DuraHeart II ventricular assist system from Terumo for an upfront cash payment of US$13 million and potential future milestone payments, based on regulatory approvals and product sales, of up to US$43.5 million.


As part of the agree- ment, a team of Terumo employees will transi- tion to Thoratec and will continue to be based in Ann Arbor, Michigan. Ad- ditionally, Thoratec and Terumo have entered into a distribution partner- ship, in which Terumo will commercialise DuraHeart II in Japan and poten- tially other parts of Asia, according to the press release.


Thoratec intends to apply its resources and expertise in mechanical circulatory support in order to advance the DuraHeart II programme


through product development and clinical trials, it was said in the release.


Thoratec anticipates a first-in-human implant of the DuraHeart-II pump in 2016 to be followed by clinical trials in the USA and other territories. Following clinical trials, the distribution partnership between Thoratec and Terumo should optimise patient access to the DuraHeart-II technology on a worldwide basis.


“DuraHeart II brings a


differentiated approach to mechanical circulatory support to Thoratec’s R&D portfolio and will be an integral component of our product development strategy, along with continued evolution of the HeartMate II system, next- generation pump platforms including HeartMate III and HeartMate PHP, which are expected to begin pivotal CE mark trials in the second half of 2013, and breakthrough cross-platform technologies such as our fully implantable system.”


7


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40