Innovative catheters - for dilating difficult lesions and delivering therapeutics to the diseased artery wall


New Market Opportunity - Therapeutic delivery: Advances in local drug delivery have proven extremely effective in the coronary arena. Drug-eluting stents have made a significant breakthrough in the prevention of in-stent restenosis. However, there are a number of areas where drug-eluting stents cannot be used effectively; namely, chronic total occlusions, peripheral artery disease, edge restenosis and vulnerable plaque. These forms of vascular disease require a catheter based method of local drug delivery, and represent significant unmet clinical needs as no available device can adequately treat these conditions. Consequently there is an opportunity to develop a more efficient and safer catheter based device.

Market Opportunity: Cutting Balloons

In order to dilate difficult/restenotic arterial lesions high-pressure angioplasty balloons are used and inflated to pressures of up to 24atm. However even at these high pressures the procedure can be unsuccessful, and when they are successful severe damage to the artery can occur. Low pressure cutting balloons were developed to eliminate excessive damage and to provide the physician with an option for dilating difficult lesions. The overall worldwide catheter market, is valued at over $15 billion and is growing at a rate of 10.4% per annum (The Biomedical Market Newsletter), with the market for specialist balloons experiencing an extremely high growth rate. In 2002 Boston Scientific stated that sales of their cutting balloon (acquired from Interventional Technologies buy-out) were up 53%, and that the cutting balloon has captured 15% of the US angioplasty balloon market. In their 2003 annual report Boston revealed that they had ~$50M increased sales of the cutting balloon. This market remains relatively unsaturated with only three products available: Guidant's FX minirail, Angioscore's Angiosculpt, and Boston Scientific's cutting balloon.

Technology Description

This Local Therapeutic Delivery platform Technology (LTDT) utilises efficient and safe device's to deliver therapeutic agents to sites of disease/damage within a blood vessel wall. NUI, Galway's technology is a catheter-based system that utilises a protective coating to conceal injection needles from the artery wall when the catheter is being advanced to its site of disease; the needles can then be exposed/re-concealed easily and safely at the site of interest. This feature allows the device to be used at more than one site; which would be useful in the common case of diffuse peripheral artery disease.
A second device called a force concentration catheter (FCC) comprises a custom protective coating that is stretch fitted over a standard balloon catheter. The protective coating contains a number of scalpels on its outer surface, which are initially concealed from the artery wall by the external contours of the coating. This allows the catheter to be navigated to the diseased portion of an artery without damaging the healthy vessel wall. These microsurgical scalpels contact the stenotic artery wall and allow a calcified lesion to be dilated in a controlled fashion. Furthermore the approach of using a protective coating to hold the microsurgical scalpels allows the product to be sold in two ways: as a stand alone catheter or as an accessory that can be retro fitted to any standard balloon angioplasty catheter in less than 10 seconds.

Principal Investigator:

Dr Bruce Murphy, NCBES, NUI Galway.

Competitive Advantage and IP Status

Specialist devices, such as Boston Scientific's cutting balloon, were conceived to successfully dilate lesions at lower pressures and reduce the damage to the artery wall. However the present generation of these devices are prone to failure [1,2,3,4], are relatively large and difficult to manoeuvre within the vasoculture [5], and are restrictively expensive [6]. We are developing a concept that overcomes a number of these limitations and will lead to the next generation of force concentration balloons and angioplasty balloon accessories that will be cheaper, more efficient, easier to use, and safer.
A patent application has been filed to protect the IP relating to the two devices described above.

References: 1. Boston Scientific news release 8th Dec 2005. 2. Cathet. Cardiovasc. Intervent. 2002;57: 239-243. 3. J Invas. Cardiol. 2002; 88: 1032-1034. 4. Cathet. Cardiovasc. Intervent. 2003;58:199-201. 5. Cardiovasc. Intervent. Radiol. 2005; 28:400-408. 6. Aliero, Business Briefing: European Cardiology 2005 p48-52.

Type of Business Sought

Licensing opportunities, joint ventures, co-development or funding to set up a spin out company.

Contacts

Dr. Daniel O'MahonyDirector, Technology Transfer Office, Science & Engineering Technology Building, National University of Ireland Galway, Ireland.
Phone: +353-91 49-2663 / 2147, Fax: +353-91-526388
Daniel.OMahony@nuigalway.ie

Dr. Maura Glennon Enterprise Ireland, Biotechnology Commercialisation Directorate (EI Bio), NUI, Galway.
Phone: +353-91 492093, Fax: +353-91-586570
Maura.Glennon@enterprise-ireland.com

NUI, Galway is the owner of all IP


EI Bio works in partnership with NUI, Galway to commercialise the technology