A novel medical device developed by Galway-based Apica Cardiovascular has the potential to revolutionise the delivery of different types of medical devices to the heart, including replacement valves. The access and closure device, which has successfully come through clinically trials and has been launched on the German market, offers a range of benefits, particularly to the mainly elderly patient population who undergo valve replacement surgery.
The company was founded in 2009 to design and develop innovative medical devices for the treatment of cardiovascular diseases which are reaching epidemic proportions in the US and are a growing problem in Europe and Japan as well.
The core technologies of Apica cardio technology and procedures were developed at Georgia Tech and Emory University, Atlanta. This technology was built on by Apica founder and CEO Jim Greene, who boasts 23 years experience in the medical device sector.
Greene established the company's headquarters in the incubation centre at National University of Ireland Galway. "We're not a US company based in Ireland – we're an Irish company, started with Irish funding as well as overseas investment. We've developed in the EU, we'll manufacture within the EU and we'll distribute and sell within the EU," he notes.
"The technology originally came out of Georgia Tech," says Apica director of R&D Brendan Cunniffe. "It was a kind of coil that can provide compression to tissue, and our CEO saw that it could have a very useful application for access and closure in cardiac surgery."
The particular type of cardiac surgery in this case is valve replacement. “When you deliver a replacement valve to a heart through a catheter system you either do it through the leg or through the apex of the heart by going in through the ribcage. About 25 per cent of valve replacements currently go through the apex.”
This is known as transapical delivery and the big issues with it for doctors are firstly how to make a hole at the apex of the heart and then how to close it with confidence that it will stay closed. “The state of the art up until the development of our device was to use suture in what is known as a purse-string method,” Cunniffe points out.
This purse-string method is aptly named as it involves putting a ring of sutures around the area at the apex of the heart where the hole will be cut and the catheter placed. Once the catheter is removed the sutures are pulled rather like shoelaces to draw the tissue together.
“The problem with this method is the age of the patients involved,” Cunniffe explains. “When we looked at one group of patients we found the average age was 82 and this is quite typical. At that age people’s heart tissue can be friable and quite weak and the suture can act like a cheese wire and cut through it. We are dealing with the left ventricle at full pressure, so that can cause real problems.”
Another issue can arise later. “Let’s assume you get good closure. The tissue is quite stressed and puckered up as a result of the purse-string closure and it will heal with scar tissue local to it. Scar tissue and normal tissue are not the same in terms of conductivity, so the presence of large amounts of scar tissue could pose potential electro-physiological problems later on.”
The Apica device, like most good ideas, is remarkably simple to describe. It is similar to a hollow screw which is inserted into the apex of the heart to make the opening and facilitate access for the catheter. Once the catheter is removed the device is simply closed at the top almost like a lid. It offers a very secure closure with much reduced levels of scar tissue and becomes encapsulated by the surrounding heart tissue as it heals over time.
“There are very definite clinical benefits offered by the device,” says Cunniffe. “One of these is reduced standard procedure time. Normally a transapical procedure takes about 90 minutes and with the Apica device it’s just short of an hour and this has clear benefits for the patient, particularly if they are elderly. And then there are the other benefits in terms of secure closure and so on.”
The device successfully came through its final clinical trial in January of this year and is now fully approved with a CE mark. "We are fortunate to have developed the device at a time when this type of surgery is on an upward surge. It has been estimated that the global market for catheter-based valve replacement systems is worth $2 billion.
"We have launched the product in Europe and we are concentrating on a number of key hospitals in Germany. We have chosen the German market because it is at the centre of the transapical valve delivery world and offers us the best commercial opportunities at the moment."
Having successfully launched this product the company is now looking at the development of other novel new devices. "We have a team of seven here in Galway and another R&D team based in Atlanta and we are working hard on the development of next generation devices in this area. We are also working hard here in Ireland with our manufacturing partner to ensure our customers in Europe have access to the supplies of the product they need."