NICE has confirmed its recommendation of Servier Laboratories’ Procoralan (ivabradine) for the treatment of chronic heart failure in final draft guidance.

The guidance states Procoralan should be taken in combination with standard therapy options or when beta-blockers are contraindicated or not tolerated – after a four week stabilisation period of standard therapy.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said the treatment “has been shown to have a beneficial effect in reducing mortality and improving quality of life in people with some types of chronic heart failure.”

Heart failure affects around 900,000 people in the UK. The most common cause of heart failure is coronary artery disease. The aim of treatment is to improve life expectancy and quality of life and to avoid patients being admitted to hospital.

“The Committee was mindful that there is robust evidence for the effectiveness of ACE inhibitors, beta-blockers and aldosterone antagonists that are used routinely in managing heart failure,” Professor Longson said.

“They concluded, therefore, that ivabradine could be considered a cost-effective use of NHS resources for treating chronic heart failure after optimal treatment with these drugs has been achieved and when patients are still symptomatic after receiving optimised initial therapies, or when beta-blockers are contraindicated or not tolerated by the patients.”

The recommendation means Procoralan can be supplied as an option for patients with systolic dysfunction, who are in sinus rhythm, whose heart rate is 75 beats per minute or more and who have a left ventricular ejection fraction of 35% or less.

The FDA has approved Cordis Corporation’s Empira and Empira NC RX PTCA dilatation catheters for the treatment of coronary artery disease.

Both balloon catheters are designed to allow cardiologists to open patients’ narrowed coronary arteries during angioplasty procedures.

Dr Campbell Rogers, Chief Scientific Officer and Global Head of R&D at Cordis, said that the company “worked closely with physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the Empira Balloon Catheters will meet physicians' needs and has the potential to improve patient outcomes”.

The two medical devices bring several design and technology alterations to Cordis’ portfolio of Empira balloon catheters. They feature the company’s next generation Duralyn Flex balloon material, which is 50% more flexible than the material used in the current Fire Star and Dura Star RX PTCA dilatation catheters, to improve crossability and recrossability, the ability to pass through a lesion.

Cordis Corporation is a Johnson & Johnson company, and develops and manufactures interventional vascular technology. The company works with interventional cardiologists, radiologists and vascular surgeons to treat patients with vascular disease.

The products are expected to be launched for sale in early 2012.

The FDA has approved Abbott’s next-generation Xience Prime drug eluting stent to treat patients with complex coronary artery disease.

The Xience Prime Everolimus Eluting Coronary Stent System is based on the company’s cobalt-chromium stent technology and is designed to enhance deliverability, flexibility, and more accurate stent placement in patients with symptomatic heart disease due to de novo native coronary artery lesions.

The approval was based on results from the SPIRIT PRIME clinical trial, a prospective, multi-centre, open-label trial involving 500 patients with coronary artery disease at more than 60 centres in the US and Australia. Clinical results show that the trial met its primary endpoint of low rates of target lesion failure (TLF) at one year.

Dr Marco Costa, principal investigator of the SPIRIT PRIME trial, said: “Drug-eluting stent technology continues to advance, leading to improved outcomes for patients with coronary artery disease.”

He said that the medical device “will improve our ability to access challenging, complex lesions, and thereby improve care for our patients”.

Robert Hance, Senior Vice President at Abbott Vascular, said that the FDA’s approval “expands the range of treatment options that we can offer physicians for the benefit of their patients with coronary artery disease”.

Xience Prime received CE Mark Approval in 2009.

Abbott recently split into two companies, one concentrating on research-based pharmaceuticals and the other (Abbott) on medical products.

A new diagnostic system that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies on a single platform has gained CE Mark approval for sale in the EU.

The Ilumien system from St. Jude Medical integrates physiological and anatomical information to improve the diagnosis and treatment of coronary artery disease.

The new system combines the PressureWire Aeris, a wireless device that measures FFR to assess the severity of blockages in the coronary arteries, with the C7-XR OCT diagnostic imaging technology. The latter’s unique intravascular imaging technology, Extreme Resolution, enables precise measurement of lesion dimensions and vessel size and structure.

Together, the two technologies enable the optimisation of percutaneous coronary intervention (PCI).

Additionally, the Ilumien system features the Wi-Box, a wireless device that receives aortic pressure readings from the catheterisation lab.

“The Ilumien system provides me and my colleagues with an easy-to-use, flexible solution that combines OCT and FFR technology,” said Dr. Evelyn Regar, Associate Professor, Department of Interventional Cardiology Thoraxcenter in Rotterdam, Netherlands. “Having these two cutting-edge technologies together is a welcome advancement for therapy guidance, allowing me to choose the right tools for each patient situation.”

“Knowing which lesion to treat and how to treat it is the key to optimizing interventional treatment strategies,” said Frank J. Callaghan, President of the St. Jude Medical Cardiovascular Division. “We believe integrating these technologies is key to providing physicians a simplified, streamlined option for the diagnosis and treatment of patients with coronary artery disease.”

St. Jude Medical is based in Minnesota, USA.

 
Ilumien system

The first selective coronary vasodilator used as a pharmacological stress agent in the diagnosis of coronary artery disease (CAD) has received a marketing authorisation in Europe.

Rapiscan (regadenoson) is a convenient bolus injection which stimulates the effects of exercise by temporarily increasing blood flow through the arteries of the heart.

Dr Brent Blackburn, Founder, President and CEO of Rapidscan Pharma Solutions, says he is “extremely excited to bring Rapiscan to Europe”.

Every year more than four million Europeans die from heart disease which accounts for almost half of the deaths in Europe. Accurate diagnosis is vital in identifying patients who need intensive medical intervention.

Diagnosis of CAD uses Myocardial Perfusion Imaging (MPI) to identify areas of poor blood flow, with more than 1.5 million Europeans undergoing tests each year. Patients are usually asked to exercise on a treadmill or bicycle, however nearly half are unable to exercise adequately.

Unlike older agents, Rapiscan requires no dose adjustment for varying body weight and its bolus dosing method takes just ten seconds, cutting out the need for an infusion pump and its set-up before the test.

“Rapiscan was designed to specifically address the needs of patients and healthcare professionals who conduct MPI tests,” said Dr Blackburn. “It’s easier to use and better tolerated than the older agents.”

Regadenoson is the most popular pharmacological stress agent in the US and has been used by more than 3 million patients since its launch in 2008.