Innovation Spotlight

Innovation Spotlight

First US Patient Enrolled in Below-the-Knee Trial for DCB

Philips announced that the first U.S. patient has been enrolled in the investigational device exemption trial of its drug-coated balloon designed to treat below-the-knee lesions.

The trial, ILLUMENATE BTK, will compare the DCB (Stellarex 0.014) to percutaneous transluminal angioplasty in patients with critical limb ischemia, according to a company press release.

The company stated that the investigators plan to enroll 354 patients at 45 sites in the U.S., Australia and Europe in the next 12 to 18 months.

“Given the challenging chronic nature of below-the-knee PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation,” Mahmood K. Razavi, MD, FSIR, FSVM, interventional radiologist at St. Joseph’s Hospital in Orange, California, co-principal investigator of the trial, said in the release.

The device has a CE mark for use in Europe but is not yet approved for use in the United States.

Steerable Introducer Under Consideration by FDA

BioCardia announced that it filed a 510(k) submission to the FDA for a steerable introducer for introducing CV catheters into the heart.

The introducer (Avance) can be used in procedures requiring transseptal delivery, including percutaneous mitral valve repair, left atrial appendage closure, patent foramen ovale and atrial septal defect repair, percutaneous left ventricular assist device replacement and atrial fibrillation ablation, according to a company press release.

The company stated in the release that the introducer is designed to be virtually whipless around curves due to helically arranged pull-wires, provides torsional stiffness and has a rotating hemostasis port.

FDA Allows Renal Denervation Study to Proceed

Medtronic announced the FDA has given it permission to begin a trial for its renal denervation system in patients with resistant hypertension who are already taking antihypertensive medications.

SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled study in which patients will be assigned to the renal denervation procedure (Symplicity Spyral) or a sham procedure, according to a company press release.

The trial will enroll up to 340 patients at 55 centers worldwide and will follow patients for 3 years, according to the release.

First-in-human Remote PCI Performed Using Telerobotic Technology

Corindus Vascular Robotics announced that the company’s proprietary technology to perform remote PCI was used in India for the world’s first-in-human telerobotic intervention study.

Remote PCI procedures were performed with the technology (CorPath System, Corindus) in five patients by Tejas Patel, MD, who was about 20 miles away, according to a company press release.

“Distance doesn’t matter,” Mark Toland, president and CEO of Corindus Vascular Robotics, told Cardiology Today’s Intervention. “This particular study happened to be 20 miles, but we’ve done cases successfully in our clinical trials up to 103 miles away. In early 2019, we plan to do a case from Boston to San Francisco.”

Another doctor was with the patient during the procedure, according to the release.

“Cardiovascular disease, including stroke, is the world’s most significant and undertreated clinical problem due to limited access to specialized, timely medical care,” Toland said in an interview. “Our technology is ground-breaking because it could eliminate some of the barriers to care, especially in rural communities. This telerobotic interventional platform has the potential to create a completely different way to treat patients that may not have access to specialized physicians.”

Abiomed Invests in Shockwave Medical

Shockwave Medical announced that it has received a $15 million investment from Abiomed and that the companies will collaborate on a training and education program for users in the United States and Germany focusing on the complementary uses of their technologies.

Shockwave makes products employing intravascular lithotripsy technology to break up vascular calcium within the vessel wall. According to a press release from Shockwave, its peripheral intravascular lithotripsy catheter (M5) is often used in patients with severely calcified iliac arteries to facilitate the transfemoral delivery of catheter-based devices such as Abiomed’s family of heart pumps (Impella).

“We are delighted to be able offer patients our solution in combination with Abiomed’s Impella technology using a minimally invasive approach, which should meaningfully improve outcomes,” Doug Godshall, president and CEO of Shockwave, said in the release. “With Abiomed’s best-in-class approach to training and education, Shockwave will be able to more efficiently increase awareness and introduce [intravascular lithotripsy] to customers, which we believe will help them better treat their most challenging patients. We are encouraged to see the positive clinical response we have witnessed to date.”

First US Patient Enrolled in Below-the-Knee Trial for DCB

Philips announced that the first U.S. patient has been enrolled in the investigational device exemption trial of its drug-coated balloon designed to treat below-the-knee lesions.

The trial, ILLUMENATE BTK, will compare the DCB (Stellarex 0.014) to percutaneous transluminal angioplasty in patients with critical limb ischemia, according to a company press release.

The company stated that the investigators plan to enroll 354 patients at 45 sites in the U.S., Australia and Europe in the next 12 to 18 months.

“Given the challenging chronic nature of below-the-knee PAD, we are hoping to find that through sustained patency using Stellarex, we can improve healing, and reduce target lesion revascularization and major amputation,” Mahmood K. Razavi, MD, FSIR, FSVM, interventional radiologist at St. Joseph’s Hospital in Orange, California, co-principal investigator of the trial, said in the release.

The device has a CE mark for use in Europe but is not yet approved for use in the United States.

Steerable Introducer Under Consideration by FDA

BioCardia announced that it filed a 510(k) submission to the FDA for a steerable introducer for introducing CV catheters into the heart.

The introducer (Avance) can be used in procedures requiring transseptal delivery, including percutaneous mitral valve repair, left atrial appendage closure, patent foramen ovale and atrial septal defect repair, percutaneous left ventricular assist device replacement and atrial fibrillation ablation, according to a company press release.

The company stated in the release that the introducer is designed to be virtually whipless around curves due to helically arranged pull-wires, provides torsional stiffness and has a rotating hemostasis port.

FDA Allows Renal Denervation Study to Proceed

Medtronic announced the FDA has given it permission to begin a trial for its renal denervation system in patients with resistant hypertension who are already taking antihypertensive medications.

SPYRAL HTN-ON MED is a prospective, randomized, sham-controlled study in which patients will be assigned to the renal denervation procedure (Symplicity Spyral) or a sham procedure, according to a company press release.

The trial will enroll up to 340 patients at 55 centers worldwide and will follow patients for 3 years, according to the release.

First-in-human Remote PCI Performed Using Telerobotic Technology

Corindus Vascular Robotics announced that the company’s proprietary technology to perform remote PCI was used in India for the world’s first-in-human telerobotic intervention study.

Remote PCI procedures were performed with the technology (CorPath System, Corindus) in five patients by Tejas Patel, MD, who was about 20 miles away, according to a company press release.

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“Distance doesn’t matter,” Mark Toland, president and CEO of Corindus Vascular Robotics, told Cardiology Today’s Intervention. “This particular study happened to be 20 miles, but we’ve done cases successfully in our clinical trials up to 103 miles away. In early 2019, we plan to do a case from Boston to San Francisco.”

Another doctor was with the patient during the procedure, according to the release.

“Cardiovascular disease, including stroke, is the world’s most significant and undertreated clinical problem due to limited access to specialized, timely medical care,” Toland said in an interview. “Our technology is ground-breaking because it could eliminate some of the barriers to care, especially in rural communities. This telerobotic interventional platform has the potential to create a completely different way to treat patients that may not have access to specialized physicians.”

Abiomed Invests in Shockwave Medical

Shockwave Medical announced that it has received a $15 million investment from Abiomed and that the companies will collaborate on a training and education program for users in the United States and Germany focusing on the complementary uses of their technologies.

Shockwave makes products employing intravascular lithotripsy technology to break up vascular calcium within the vessel wall. According to a press release from Shockwave, its peripheral intravascular lithotripsy catheter (M5) is often used in patients with severely calcified iliac arteries to facilitate the transfemoral delivery of catheter-based devices such as Abiomed’s family of heart pumps (Impella).

“We are delighted to be able offer patients our solution in combination with Abiomed’s Impella technology using a minimally invasive approach, which should meaningfully improve outcomes,” Doug Godshall, president and CEO of Shockwave, said in the release. “With Abiomed’s best-in-class approach to training and education, Shockwave will be able to more efficiently increase awareness and introduce [intravascular lithotripsy] to customers, which we believe will help them better treat their most challenging patients. We are encouraged to see the positive clinical response we have witnessed to date.”