|A balloon postprocessing technique from Interface Catheter Solutions produces a textured surface (left). In contrast, balloons that have not undergone the process have smooth surfaces (right).|
While coronary stents—both the bare metal and drug eluting varieties—have revolutionized the field of interventional cardiology, they are not without drawbacks. In response, medical device manufacturers are either working to improve stent designs or developing alternative technologies, such as drug-eluting or electronics-laden balloons. One such manufacturer is Interface Catheter Solutions (Laguna Niguel, CA), which offers drug-eluting balloons that could prove useful in treating stenosed arterial vessels and in-stent restenosis.
Supporting the development of drug-eluting balloons, the company has developed a surface-texturing technology that facilitates the process of coating balloons with a drug. Normally, the surface of such balloons is smooth, making them difficult to coat, explains Mark Geiger, vice president of sales and marketing at Interface Catheter Solutions. The traditional method of overcoming this challenge is to coat the balloon with a polymer, which serves as a primer before it is ‘painted’ with a drug layer. In contrast, the company has developed a balloon with a textured surface that avoids the need for this coating. After producing the balloon, the company applies its surface-treatment process to create a textured surface, increasing the surface area and improving the ability of a drug to bond to the balloon.
While it remains to be seen which technology—drug-eluting balloons or balloons equipped with electronics—will ultimately have a bigger impact on interventional cardiology, the field of flexible electronics is gaining steam. “With the advent of companies like MC10, the use of the balloon, which is such a familiar platform, could really be extended by using them in conjunction with electronics,” Geiger comments. “The two applications that have risen to the top in those discussions are renal denervation (RDN) and atrial fibrillation.”
For treating atrial fibrillation, balloons with mounted electronics can be used to both sense and ablate tissue. RDN, on the other hand, appears to be an effective method for treating hypertension in patients that are not responsive to drug therapy. Highlighting the importance of RDN, Geiger notes that both Medtronic and Boston Scientific have acquired companies that focus on renal denervation technologies. Based on Interface Catheter’s surface-modified balloons, for example, Boston Scientific’s Vessix Vascular Inc. provides balloon-based RDN systems with embedded flexible electrodes that can perform renal denervation procedures in 30 seconds per artery.
Although balloons are not used universally to perform RDN, a growing number of firms have become interested in balloon-based technologies with electronics mounted onto them, according to Geiger. “These types of technologies are different from each other, but they all use a balloon with some sort of electronics mounted on it,” he says. “It is really the convergence of the unmet clinical need, the familiar platform in balloon technology, and the advent of flexible electronics that have really allowed this to be realized.”