Strategic Partnerships Bring Higher Levels of Sophistication to Cath Labs

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GE Healthcare partnered with Biosense Webster so GE’s Vivid i compact echo system could be integrated with the AcuNav 2D intracardiac echo (ICE) from Biosense.
Cath labs are experiencing phenomenal change, as their volume decreases and cases become more complex. This is especially reflected in the way vendors have teamed up to offer interventional cardiologists more and varied options to diagnose and treat patients.

Results of the FAME study, published earlier this year in the New England Journal of Medicine, validated fractional flow reserve (FFR) as an index for functional severity of coronary stenosis prior to PCI. FFR allows interventional cardiologists to stent only those lesions that fail to pass a blood-flow threshold, as opposed to stenting lesions based on angiographic characteristics. The results of FAME were hailed as nothing short of revolutionary, but this type of excitement has permeated almost every area of the cath lab as more sophisticated technology takes hold.

Helping cath labs enter the 21st century are a number of strategic partnerships among vendors that will help integrate various technologies in an effort to make cath labs more user-friendly and efficacious. On the heels of the preliminary release of the FAME trial results last year, for example, GE Healthcare announced it was teaming with Radi Medical Systems, makers of the Certus pressure wire used in the trial (Radi has since been purchased by St. Jude Medical). The partnership means that FFR capabilities will be seamlessly integrated into the GE Mac-Lab IT hemodynamic recording system. Prior to this partnership, FFR equipment had to be wheeled into the cath lab and cables needed to be hooked up, which “met with some resistance from staff,” says Jim Archetto, president of Radi.

About half of the interventional labs in the U.S. have FFR capability, with either the Radi or Volcano Medical pressure wires, Archetto says. While the growth of new business is encouraging, the penetration rate, or the actual number of PCI cases where FFR is used, is low, about 10 percent. With the convincing FAME results and the GE partnership, Archetto expects the utilization of FFR, as well as the number of installations, to climb significantly.

Another partnership brought together Biosense Webster’s AcuNav 2D intracardiac echo (ICE) catheter and GE’s Vivid i compact echo system. The idea is to deliver real-time image guidance for complex interventional cardiology and electrophysiology procedures in a space-saving compact echo design.

GE also teamed up last year with Boston Scientific to integrate the latter’s intravascular ultrasound (IVUS) system with the former’s Innova cath lab x-ray system. Boston Scientific’s iLab can be directly installed into the Innova, which enables improved IVUS workflow between the two systems. “We recently installed an iLab system alongside our GE cath lab and have found that the use of both technologies has improved the ease of use in performing IVUS,” says Francis Boucek, MD, of Naples Community Hospital, Fla.

Hybrid cath labs

Last year, Philips Healthcare teamed up with Skytron to provide hybrid surgical rooms that will easily accommodate minimally invasive procedures. Philips will provide interventional x-ray equipment and specialized imaging tables, while Skytron will deliver advanced operating room communications control integration, surgical lighting and boom technologies specifically designed to support hybrid surgical suites. Bert van Meurs, senior vice president of cardiovascular x-ray for Philips, says that the partnership will allow them to deliver “operating rooms that optimize workflow while reducing the length of the planning and installation process.”

Philips also partnered with Steris Corporation, again to enhance hybrid operating room installation and operation. Philips expects its Allura Xper cardiovascular x-ray system and the Steris HD 360° Suites technologies to seamlessly integrate and create a “flexible environment where clinicians can treat patients requiring minimally invasive procedures, or those needing open surgery, within a single operating suite,” according to van Meurs. He adds that the growth in outpatient procedures, along with the rise in catheter-based treatment, demands that hospitals reassess the configuration of operating rooms “so they can adapt easily to different surgical procedures and accommodate a wide range of current and future surgical technologies.”

Rebranding

Volcano began as a company that specialized in the use of IVUS to view vulnerable plaque, but is now morphing into a company that provides various diagnostic and therapeutic technologies for the cath lab.

One new product in the pipeline is image-guided therapy with IVUS on balloon catheters. The product, which includes compliant and noncompliant versions for coronary and peripheral vasculature, is expected to come to market in the beginning of 2010, according to Scott Huennekens, CEO of Volcano. Another product soon to be offered is a forward-looking IVUS therapeutic device that includes an image-guided crossing catheter that combines visualization, steerability and RF tissue ablation. It is designed to help interventional cardiologists safely cross chronic total occlusions (CTOs) in the coronary and peripheral arteries. There also is an imaging-only version to facilitate current guidewire-based CTO crossing techniques. These products will be available within the next two years.

A third product that the company expects to add to its IVUS console is optical coherence tomography (OCT). This modality has a spatial resolution of 10 to 15 microns and has shown promise in imaging stent struts to determine healing patterns, as well as other applications. In addition, the company last year introduced a rotational IVUS catheter, which, along with its single-use phased array catheter, will be integrated into the main console, along with FFR and ICE. Volcano has entered into partnerships with the major cath lab vendors such as GE, Philips and Siemens Healthcare, as well as Johnson & Johnson and Medtronic, for smooth integration of its interventional console with various systems.

Integrating robotics

Hansen Medical, which develops products and technology using robotics to position, manipulate and control catheters and catheter-based technologies, has teamed with several partners to extend the reach of its technology. Earlier this year, Philips and Hansen announced an agreement to co-develop integrated products that may simplify complex cardiac procedures to diagnose and treat arrhythmias. The agreement will combine Philips’ Allura with the Hansen Sensei robotic catheter system. The Sensei is a robotic navigation system that enables clinicians to place mapping catheters in hard-to-reach anatomical locations within the heart.

Last year, GE and Hansen also teamed up to allow seamless integration of the Sensei robotic catheter system with GE’s Innova. Laurence Epstein, MD, director of Brigham and Women’s Electrophysiology Lab, has experienced the benefits of having the Sensei integrated with the Innova fluoroscopy system. “The workflow is much improved and the compatibility has been seamless,” Epstein says. “The combination helps us maximize patient care and minimize procedure time.”

The future

It’s difficult in this space to cover all the strategic partnerships or company strategies that have helped elevate the level of sophistication in the cath lab. Suffice it to say that interventional cardiologists have a wide array of diagnostic and therapeutic tools at their disposal, tools that allow them to perform procedures that are more complex, in a more timely manner, with better outcomes than was possible five or 10 years ago. In the future, vendors will continue to refine products for the cath lab on an individual basis, as well as collaboratively.