Study shows innovation is required closer to the cardiologist
Leading cardiologists call for better kink resistance in hypotube design to reduce procedure time and cost, and improve patient recovery time and safety.
In a study released today by Cambridge Consultants, leading cardiologists from the USA and Europe call for greater innovation in the design of hypotubes, which are used in percutaneous coronary interventional (PCI) procedures. Over 5 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 high-profile 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. "With real clinician insight it is possible to identify hidden issues that impact medical device performance – and to innovate even well-established products so they deliver time- and cost-saving benefits for both doctor and patient."
To download the study in full, click here.
Notes to Editors
Over 5 million diagnostic and therapeutic interventional cardiology procedures were performed in the US in 2004, generating more than $4.9 billion in corresponding product sales. An ageing population and lifestyle challenges are heavily impacting on the growth in the number of cardiovascular disease sufferers, so much so that by 2009 sales of interventional cardiology products are expected to reach $6.4 billion (U.S. Markets for Interventional Cardiology Products 4Q 2005, MedTech Insight, October 2005).
Cambridge Consultants has, for over 40 years, enabled its clients to turn business opportunities into commercial successes, whether launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. We develop breakthrough products, create and license intellectual property, and provide business consultancy in technology critical issues for clients worldwide. With a team of over 200 engineers, scientists and consultants, in offices in Cambridge (UK) and Boston (USA), we are able to offer solutions across a diverse range of industries including healthcare, industrial and consumer products, automotive, transport, energy and wireless communications.
