As part of its efforts to expand integration of intravascular ultrasound (IVUS) image guidance with cath lab treatment devices, Volcano Corp. recently announced a supply agreement with ev3, a Covidien company. Volcano will supply its IVUS technology for use in ev3’s TurboHawk plaque excision (atherectomy) systems.

Volcano developed an IVUS-guided balloon catheter, the Vibe RX, which is available in Europe. The company plans to partner with other vendors to create a line of IVUS-guided therapy solutions.

These are some of the top cardiology technology news items from the spring and early summer 2011. As part of its efforts to expand integration of intravascular ultrasound (IVUS) image guidance with cath lab treatment devices, Volcano Corp. recently announced a supply agreement with ev3, a Covidien company. Volcano will supply its IVUS technology for use in ev3’s TurboHawk plaque excision (atherectomy) systems.

Computed tomography angiography (CTA) is one of the most complex procedures routinely performed on a CT scanner. A successful CTA exam requires synchronization of the timing of the scan with maximum vessel contrast enhancement.

July 15, 2011 — In a true hybrid suite, both cath lab and open surgical procedures are performed in a single room. In creating hybrid cath labs, healthcare facilities require imaging technologies that provide the flexibility to quickly and easily access both the patient and ancillary equipment. Arnold Palmer Hospital for Children in Orlando, Fla., a leading children’s hospital, recently installed Toshiba America Medical Systems Inc.’s Infinix CF-i bi-plane system with the CAT-880B hybrid catheterization table for its new dedicated hybrid suite. When combining the five-axis positioner of the Infinix-i system with the tilting and cradling features of the hybrid table, physicians are able to obtain optimal image angles while having unprecedented patient access.

July 14, 2011 – Cambridge Heart Inc., a developer of non-invasive diagnostic tests for cardiac disease, announced that it has reached an agreement with its original equipment manufacturing (OEM) partner, Cardiac Science Corporation, to include Cambridge Heart’s proprietary microvolt T-wave alternans (MTWA) module on every new Q-Stress system sale beginning July 11, 2011.  The company expects this initiative to significantly increase the placement of MTWA modules in coming quarters, which Cambridge Heart anticipates will provide the basis for future recurring revenue.

 

July 14, 2011 — Boston Scientific Corporation has completed patient enrollment in the ASTI post-market clinical follow-up study evaluating its Adapt Monorail carotid stent system in combination with its FilterWire EZ embolic protection system for treatment of carotid artery disease in patients at high risk for carotid surgery.

July 14, 2011 – Endosense, a Swiss medical technology company, has announced completion of the first patient case utilizing prototype software that integrates the contact-force data provided by Endosense’s TactiCath force-sensing ablation catheter with Siemens Healthcare’s electrophysiology solutions.


Carotid stenting is a more complex and challenging procedure than coronaries or peripheral vessels. Carotid stenting experts have the following advice for hospitals and physicians that want to enter this market.

July 14, 2011 — The U.S. Food and Drug Administration (FDA) has conditionally approved the protocol for SYMPLICITY HTN-3, the U.S. clinical trial of renal denervation with the Symplicity catheter system for the treatment of resistant hypertension (high blood pressure in the presence of three or more medications). Patient enrollment in the landmark study is expected to start soon.


In a move that will likely have a significant impact on how many patients are treated for carotid artery disease, the U.S. Food and Drug Administration (FDA) in May cleared the use of a stent to treat standard-risk surgical patients. Prior to this approval, carotid stenting was only indicated for use in high-risk surgical patients who were often denied the standard-of-care of carotid endarterectomy surgery.
The decision to expand the indication for the Abbott RX Acculink carotid stent system is expected to have a major impact, offering patients the option of minimally invasive stenting rather than open surgery, which often leaves scars on the patient’s neck.
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