Johns Hopkins Medicine International (Baltimore) and Sanofi-Aventis Egypt (Cairo) have signed an agreement for educational and consultative services through the Johns Hopkins Division of Cardiology.

The agreement calls for assistance with the development of new national guidelines on cardiovascular disease prevention. Other services in the agreement include support in training of primary care physicians and cardiologists in cardiovascular disease prevention and patient education.

According to Johns Hopkins, Egypt has among the highest incidences in the world of hypertension, obesity, smoking, Type 2 diabetes and other risk factors leading to heart disease.

In Egypt, this initiative is referred to as the Delta-C Project, a model for change. The Delta concept was originated by Innovara (Hadley, Massachusetts), a healthcare consulting firm that has facilitated the relationship between Johns Hopkins and the Egyptian cardiology community.

Dr. M. Mohsen Ibrahim, professor of cardiology at Cairo University and president of the Egyptian Hypertension Society (Cairo), is chairman of the Delta-C project. Focusing on prevention is critical both socially and economically, Ibrahim said, because Egyptians have among the highest rates of cardiovascular disease in the world.

On Dec. 8-9, a major physician re-education event hosted by Sanofi-Aventis Egypt launched the new guidelines while also training cardiologists to train primary care physicians throughout the country. Training throughout the two-day event included case studies, medical training in cardiovascular disease prevention, advances in the use of new cardiovascular medicines in disease prevention, and plans for a patient intervention study to measure the effect of prevention education on cardiovascular disease outcomes.

The training was conducted by a team of cardiologists who also have helped to author the Delta-C guidelines, under the leadership of Ibrahim and with additional guidance from Dr. Richard Lange, chief of clinical cardiology at Johns Hopkins Medicine.

The guidelines detailed in the Delta-C initiative address both lifestyle modification and drug therapy for established risk factors, Ibrahim said. Having the Johns Hopkins guidance in such an initiative brings credibility and value to the project as a whole, he said.

Ibrahim said that two complementary prevention strategies are needed in Egypt, one directed to the whole population to decrease the risk profile of the community, and another that approaches individuals in high risk of cardiovascular disease. The guidelines also call for complete smoking cessation and education on the hazards of an increasingly unhealthy dietary style.

The Delta-C project is licensed from Innovara by Sanofi-Aventis Egypt for use by the Egyptian Hypertension Society. Innovara also serves as advisor to the project.


F&S: catheters, guidewires sectors strong

Demographic changes, a boom in cardiac care and the increasing prominence of minimally invasive surgeries have triggered the need for multi-purpose, cost-efficient product offerings in the European market for catheters and guidewires for angioplasty and angiography, according to global consulting firm Frost & Sullivan (F&S; London). In a new report, "The European Market for Catheters and Guidewires for Angioplasty and Angiography," F&S says that innovative and cost-effective products will be "critical" to injecting new momentum into this relatively mature market. It estimates that the European market for such products will total $374 million as of year-end.

"The market in Europe is being driven by changes in demographics, the rising importance of cardiac care and the expansion of minimally invasive surgeries," notes Research Analyst Sowmya Rajagopalan. "The ability to provide painless and effective treatment together with multi-purpose product features will be key to improving market penetration and revenues."

The dominance of a few major companies in the space poses a challenge to smaller competitors. "Advances in alternative technologies and financially constrained hospitals favoring bulk purchases from companies with a broad product range are creating further difficulties for many market partici-pants,"according to the report.

It said that despite the development of many novel alternative technologies, catheter angioplasty and angiography continue to retain a "strong market hold" due to their simple and effective treatment methods. "The emergence of new products such as catheters attached with guidewires and multi-purpose angiography catheters also bodes well for market growth," Rajagopalan said. Such improvements will be critical to combat the threat posed by multi-purpose products based on alternative new technologies, according to Frost & Sullivan.

Rajagopalan cited the need for continued R&D to help produce novel, cost-efficient, superior and multi-purpose products, saying that need is being further highlighted by "ongoing healthcare reforms that have resulted in severe pricing pressures." She said the trend toward price reduction "is minimizing company bottom lines," adding that "by aligning


Asset 2 'toolkit' offered as new aid to UK stroke services

A new electronic "toolkit" for the staff of the National Health Service, launched by the UK Department of Health, is intended to help transform the lives of stroke suffers, according to Health Minister Rosie Winterton. The computer-based program, called Asset 2, has been developed to assist healthcare commissioners in modernizing their services, preventing thousands of strokes in the process. Aimed at Primary Care Trusts and general practitioners, the web-based system identifies levels of demand for services in an area, benchmarks current services against other organizations, identifies best practices and demonstrates the impact of changes.

Launching Asset 2 at the annual UK Stroke Forum Conference in Harrogate, sponsored by The Stroke Association (London), Professor Roger Boyle, national clinical director for stroke services, said, "If healthcare commissioners use this tool and follow its recommendations, lives will be saved."

The guide encourages four key changes:

  • Increasing stroke unit capacity.
  • Providing quicker access to transient ischemic attack (minor stroke) services.
  • Rapid scanning to enable greater use of clot-busting drugs.
  • Early supported discharge.

If all services made these changes, then each year 840 strokes would be avoided, and 3,900 sufferers would regain their independence rather than facing the prospect of death or long-term dependency, the developers have said. Another 20,000 strokes could be avoided through preventive work on high blood pressure, irregular heartbeats, smoking cessation and wider statin use.

Winterton has asked Boyle to develop a stroke strategy, and his expert groups are to report their recommendations in 2007.

Boyle said, "The toolkit will complement the work already under way on our stroke strategy and shows the NHS can start making changes to stroke care today. Two-thirds of stroke patients now spend time on a stroke unit, where they have access to highly trained staff and excellent post-stroke care, including support for swallowing, speech, mobility and daily living activities."

Joe Korner, director of communications at The Stroke Association, said, "We are fully behind the progress that has already been made improving and shaping stroke services."


China study enrollment of LeMaitre graft trial completed

LeMaitre Vascular (Burlington, Massachusetts) reported the enrollment of the 30th and final patient in the EndoFit Thoracic Stent Graft Clinical Study in China.

The company said the objective of the study is to obtain data that will support approval of the EndoFit Thoracic Stent Graft from the Chinese State FDA (SFDA). It said completion of patient enrollment marks the start of a six-month follow-up and observation period.

George LeMaitre, president/CEO and chairman of the company, called the enrollment figure "a key regulatory milestone in this rapidly emerging endovascular device market."

The EndoFit Thoracic Stent Graft is used to treat aortic aneurysms. The device's encapsulated design prevents its stents from contacting the bloodstream or the vessel wall, thus allowing a wider range of stent graft sizes, including tapered and custom grafts, to fit a wider range of patient anatomies than many competing products.

Dr. Weiguo Fu, director of the endovascular department at China Fudan University Zhongshan Hospital, said, "The radial force of the proximal end of the EndoFit Thoracic Stent Graft seems superior, as we have not seen any migration post-implantation. Also, the flexibility of the delivery sheath allows for a controllable delivery around the aortic arch." Fu is participating is the study along with Dr. Wei Guo of Beijing 301 Hospital and Dr. Shangdong Xu of Beijing Anzhen Hospital.

The EndoFit Thoracic Stent Graft is currently sold in the European Union and a small number of other foreign jurisdictions. It is not cleared for sale in the U.S.


Value of Lucas Chest Compression System backed by data

The city of Lund, Sweden, has from 2003 to 2005 claimed the top position in the Swedish National Registry of Cardiac Arrest statistics for one-month survival rates of out-of-hospital cardiac arrest victims.

A presentation at last month's Swedish CPR (CardioPulmonary Resuscitation) congress in Gothenburg strongly indicated that KAMBER, the organization of pre-hospital care in the region, has found an efficient way to save more lives. Some 13.7% of the victims in Lund are alive one month after the event, close to double the Swedish national average of 7.3%.

A key factor in this finding is the implementation of the automatic Lucas Chest Compression System from Swedish firm Jolife (Lund, Sweden) in all ambulances. Lucas provides mechanical compressions, which helps to ensure critical circulation to the heart and brain in a situation where time is limited. The Lucas Chest Compression System provides continuous compressions, which ensures blood flow to the brain and heart.

"[Our] focus has been to optimize the ability to give enduring CPR with good quality over time, with a minimum of exposure for EMS personnel to traffic hazards during transportation," said Dr. Johan Silfverstolpe, MD, of KAMBER.

"KAMBER is a pioneer worldwide in implementing Lucas," said Jolife CEO Erik von Schenck. "The Lucas device was deployed in service in 2002, and it's very exciting to follow the progress in survival rates." He added that the experiences of the company's Swedish and other European customers are "very encouraging," particularly since Jolife is currently introducing Lucas widely in Europe and the U.S."


CorNova bare-metal coronary stent wins CE mark

Implant Sciences (Wakefield, Massachusetts) reported that CorNova (Munchen, Germany), the wholly owned German subsidiary of CorNova Inc. (Burlington, Massachusetts), recently received CE-mark approval for its Valecor Coronary Stent System.

Holder of an 18% ownership interest in CorNova, Implant Sciences said that the company's cobalt-chromium stent uses an innovative design that was developed to maximize flexibility and conformity while providing uniform expansion and coverage. With some of the thinnest struts of any commercialized coronary stent, the Valecor stent minimizes strut thickness, which CorNova said is believed to play a significant role in reducing restenosis.

Dr. Eric Ryan, chairman and CEO of CorNova, said, "We believe this bare-metal stent system illustrates exceptional characteristics that may position it well within the approximately $1 billion international bare-metal stent market. We also believe the Valecor stent could provide a platform for promising passive and drug-eluting coating systems, which are currently under development."

Dr. Anthony Armini, PhD., Implant Sciences' CEO, staid, "We believe the passive coating technology we have developed with our strategic partner, CorNova, could have the potential to improve the biocompatibility of non-drug-eluting stents. Combined with CorNova's drug-eluting polymer and other advanced endovascular technologies, we believe this could contribute to an advancement in drug-eluting stent performance."

Implant Sciences is using its ion technology to develop products for the homeland security, medical device and semiconductor industries. The company sells radioactive products for the treatment of cancer, including sales of radioactive seeds for the treatment of prostate cancer and development of a new, FDA-approved radioactive source for use in the treatment of breast cancer.

CE-mark approval allows the Valecor stent system to be sold in all European Union countries, as well as many other countries worldwide that accept this approval for registration within those countries. CorNova currently has sales and distribution offices in Munich, Germany and Buenos Aires, Argentina.


Cinvention, Relisys extend cobalt/chromium stent pact

Cinvention (Wiesbaden, Germany) reported the extension of a license and supply agreement with Relisys Medical (Hyderabad, India) for manufacturing, global marketing and sales of a non-eluting coronary stent with a bioactive nano-structured carbon-composite coating with pro-healing properties.

Relisys says its cobalt/chromium stent is coated with a porous carbon/carbon composite nano-structured matrix with a surface design for improved endothelialization. Dr. N. Krishna Reddy, chairman of Relisys, said, this version of a coronary stent has the potential to overcome concerns with current drug-eluting stents (DES).

Krishna Reddy pointed out that the animal study results by the Cardiovascular Research Institute (Washington), published last April, made it evident that the bioactive nano-porous carbon coating, that requires no polymer, might address the issues of endothelialization, thrombosis, and continuing inflammation, the issues of concern with polymer-based DES devices.

The coating was developed by Cinvention, formerly Blue Membranes, which says that the coating provides a bioactive surface with less thrombogeneity and pro-endothelialization properties, thus reducing tissue inflammation and reaction, but enhancing engraftment.Relisys said it is in ongoing animal trials to validate the stent and will seek CE mark approval for the stent this year.

Advanced Magnetics develops nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as imaging agents to aid in the diagnosis of cancer and cardiovascular disease.