Cardiologists call for innovation

In a study released today by

, leading cardiologists from the

and

call for greater innovation in the design of hypotubes, which are used in percutaneous coronary interventional (PCI) procedures.

Over five million diagnostic and therapeutic interventional cardiology procedures were performed in the US alone in 2004, creating a $5 billion market in corresponding product sales, which is projected to grow to $6.4 billion in the US by 2009. Today’s study concluded that in particular, improved kink resistance in the hypotubes is needed, and will vastly benefit both the cardiologist and the patient by saving surgeon time and reducing patient risks and recovery time.

The study was completed at the end of 2005 following in-depth interviews with cardiologists in the USA, Germany and the UK. All cardiologists involved in the study indicated that catheter delivery systems are the first key step in successful stent treatment, as delivery systems are what enable stents to arrive at the target lesion. While cardiologists are generally satisfied with current delivery systems, they expressed the need for improvements to hypotube kink performance, since an immense amount of force has to be exerted on the proximal end of the catheter when negotiating tortuous anatomy or inaccessible lesions.

If a catheter fails to cross a heavily calcified lesion it may kink, reducing the overall ‘pushability’ of the catheter and making it difficult to place the balloon and stent into the target lesion accurately. In addition, kinking may compromise the hypotube’s cross section, impacting balloon deflation. This increases the difficulty of balloon removal as well as the risk of damage following a lack of blood supply downstream. Although rare, a severe kink could also lead to breakage and emergency interventional surgery."

“If I am worried that the catheter shaft is going to kink given the force required to reach and cross a lesion, I will replace it with a different catheter until I can successfully cross the lesion," said Dr. F. S. Resnic MD M.Sc., of Brigham and Women’s Hospital in Boston, who took part in the study. "This leads to longer more expensive procedures. A hypotube with increased kink resistance would have a higher failure point, so I can use a higher force to be able to deliver the stent with confidence."

"Successful innovation is not just about focusing R&D effort on the high-value end of the market, but on seemingly simple components of devices that are critical for optimal outcomes," said Dr. Clare Beddoes, a consultant at Cambridge Consultants, who authored the study.

A copy of the report can be found here.