Innovation Spotlight

Innovation Spotlight

First US Patient Implanted With Novel TAVR Valve

JC Medical announced that the first U.S. patient was successfully treated with its novel transfemoral transcatheter aortic valve replacement system.

The device (J-Valve TF system) is designed for patients who require TAVR due to aortic regurgitation, according to a press release from the company.

“This valve has unique properties, one of which is anchor rings which land in the coronary sinuses,” Cardiology Today’s Intervention Editorial Board Member Dean J. Kereiakes, MD, FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center and the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati and professor of clinical medicine at Ohio State University, who performed the first U.S. procedure, said in an interview. “Even though the annulus is difficult to see because it is not heavily calcified, you can see when the anchor rings engage it, and then the device aligns itself as the anchor rings steer it into the coronary sinuses. This allows for better orientation of the valve and locks it into the sinuses, even in a native valve that is not calcified. These self-aligning and localizing characteristics are truly remarkable.”

A U.S. clinical trial of the device, which is not yet approved for use in the U.S., is scheduled to launch in 2019, according to the release.

Registry Launched to Study Clots Retrieved via Mechanical Thrombectomy

Johnson & Johnson announced its Cerenovus business launched the EXCELLENT registry to analyze clots removed from patients with ischemic stroke by its next-generation stent retriever.

According to a press release from the company, the registry will include up to 1,000 patients treated with the stent retriever (Embotrap II Revascularization Device) in mechanical thrombectomy procedures.

The mission of the registry is to determine how clot characteristics affect patient comorbidities, clinical outcomes and revascularization rates, the company stated in the release.

The company also announced it received a CE mark for its novel device (Geometric Clot Extractor Revascularization Device) for retrieving clots resistant to traditional mechanical thrombectomy procedures.

Trial of Intravascular Lithotripsy in Coronary Arteries Commences

Shockwave Medical announced the first patient was enrolled in the DISRUPT CAD III pivotal trial of its intravascular lithotripsy device in patients with heavily calcified coronary arteries.

According to a press release from the company, the device (Shockwave Coronary IVL system with the Shockwave C2 Coronary IVL catheter) delivers pulsatile sonic pressure waves similar to those used to treat kidney stones to break up calcium, prevent arterial trauma and facilitate stent implantation.

The need for a treatment for calcified arteries without the drawbacks of the current technologies “has never been more necessary than now, and is driven by the aging population, the epidemic of diabetes and the higher prevalence of chronic kidney disease, all of which are significantly correlated with vascular calcification,” Dean J. Kereiakes, MD, FACC, FSCAI, a member of the Cardiology Today’s Intervention Editorial Board, said in an interview. “Now, we have a technology that is balloon-based with a short learning curve, which if we can get it into position, can impact calcium throughout the wall of the vessel, changing transmural compliance of the vessel, which should optimize stent deployment. Unlike other currently available systems, there is no barotrauma associated with high-pressure balloon inflation, which can cause dissection, vessel or balloon rupture. With Shockwave IVL, we can do low-pressure inflations with no barotrauma and great-looking results.”

The coronary version of the device is not yet approved for use in the United States, but a larger version (Shockwave M5) is approved to treat calcified lesions in peripheral arteries, including to facilitate transfemoral access for procedures such as transcatheter aortic valve replacement.

“The ability to approach a heavily calcified vessel that you can’t get any catheter through with Shockwave, and then to be able to open a balloon at low atmospheric pressure and pass a large-bore catheter for TAVR, endovascular aneurysm repair or mechanical cardiac support, is truly remarkable, and something we’ve not been able to do,” Kereiakes, medical director of The Christ Hospital Heart and Vascular Center and the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati and professor of clinical medicine at Ohio State University, who is co-principal investigator of the trial, told Cardiology Today’s Intervention. “This technology can make tough cases easier.”

First US Patient Implanted With Novel TAVR Valve

JC Medical announced that the first U.S. patient was successfully treated with its novel transfemoral transcatheter aortic valve replacement system.

The device (J-Valve TF system) is designed for patients who require TAVR due to aortic regurgitation, according to a press release from the company.

“This valve has unique properties, one of which is anchor rings which land in the coronary sinuses,” Cardiology Today’s Intervention Editorial Board Member Dean J. Kereiakes, MD, FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center and the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati and professor of clinical medicine at Ohio State University, who performed the first U.S. procedure, said in an interview. “Even though the annulus is difficult to see because it is not heavily calcified, you can see when the anchor rings engage it, and then the device aligns itself as the anchor rings steer it into the coronary sinuses. This allows for better orientation of the valve and locks it into the sinuses, even in a native valve that is not calcified. These self-aligning and localizing characteristics are truly remarkable.”

A U.S. clinical trial of the device, which is not yet approved for use in the U.S., is scheduled to launch in 2019, according to the release.

Registry Launched to Study Clots Retrieved via Mechanical Thrombectomy

Johnson & Johnson announced its Cerenovus business launched the EXCELLENT registry to analyze clots removed from patients with ischemic stroke by its next-generation stent retriever.

According to a press release from the company, the registry will include up to 1,000 patients treated with the stent retriever (Embotrap II Revascularization Device) in mechanical thrombectomy procedures.

The mission of the registry is to determine how clot characteristics affect patient comorbidities, clinical outcomes and revascularization rates, the company stated in the release.

The company also announced it received a CE mark for its novel device (Geometric Clot Extractor Revascularization Device) for retrieving clots resistant to traditional mechanical thrombectomy procedures.

Trial of Intravascular Lithotripsy in Coronary Arteries Commences

Shockwave Medical announced the first patient was enrolled in the DISRUPT CAD III pivotal trial of its intravascular lithotripsy device in patients with heavily calcified coronary arteries.

According to a press release from the company, the device (Shockwave Coronary IVL system with the Shockwave C2 Coronary IVL catheter) delivers pulsatile sonic pressure waves similar to those used to treat kidney stones to break up calcium, prevent arterial trauma and facilitate stent implantation.

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The need for a treatment for calcified arteries without the drawbacks of the current technologies “has never been more necessary than now, and is driven by the aging population, the epidemic of diabetes and the higher prevalence of chronic kidney disease, all of which are significantly correlated with vascular calcification,” Dean J. Kereiakes, MD, FACC, FSCAI, a member of the Cardiology Today’s Intervention Editorial Board, said in an interview. “Now, we have a technology that is balloon-based with a short learning curve, which if we can get it into position, can impact calcium throughout the wall of the vessel, changing transmural compliance of the vessel, which should optimize stent deployment. Unlike other currently available systems, there is no barotrauma associated with high-pressure balloon inflation, which can cause dissection, vessel or balloon rupture. With Shockwave IVL, we can do low-pressure inflations with no barotrauma and great-looking results.”

The coronary version of the device is not yet approved for use in the United States, but a larger version (Shockwave M5) is approved to treat calcified lesions in peripheral arteries, including to facilitate transfemoral access for procedures such as transcatheter aortic valve replacement.

“The ability to approach a heavily calcified vessel that you can’t get any catheter through with Shockwave, and then to be able to open a balloon at low atmospheric pressure and pass a large-bore catheter for TAVR, endovascular aneurysm repair or mechanical cardiac support, is truly remarkable, and something we’ve not been able to do,” Kereiakes, medical director of The Christ Hospital Heart and Vascular Center and the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital in Cincinnati and professor of clinical medicine at Ohio State University, who is co-principal investigator of the trial, told Cardiology Today’s Intervention. “This technology can make tough cases easier.”