FDA Clearance Archives - Cardio Flow, Inc.

Cardio Flow Announces Completion of First Commercial Cases

Andrew Luce — Mon, 30 Oct 2023 21:09:10 +0000

PRESS RELEASE | FOR IMMEDIATE RELEASE | Download press release

St. Paul, MN – October 30, 2023. Cardio Flow, Inc., a privately held commercial-stage medical device company and developer of minimally invasive devices to treat peripheral artery disease (PAD), is pleased to announce the successful completion of its first commercial cases for its FreedomFlow® Orbital Atherectomy Platform following FDA clearance in late September.

First Commercial Case Performed at the Cardiovascular Institute of the South (CIS)

Cardio Flow announced the successful completion of its first commercial cases in leading medical centers across the U.S. The initial cases were performed by Drs. Craig Walker, Pradeep Nair, and McCall Walker of the Cardiovascular Institute of the South (CIS) at the Terrebonne General Health System in Houma, LA.

FreedomFlow treats plaque blockages in the legs, and its unique technology gives physicians greater versatility in treating multiple arteries and multiple blockages in the same vessel—all with a single device. The first patient treated at Terrebonne had a complex arterial anatomy and multiple blockages with extensive calcium, including a chronic total occlusion. FreedomFlow’s dynamic new mechanism of action demonstrated its effectiveness in these initial procedures.

L to R - Elizabeth Harrington, RN; Brandon Inness, RN; Steve Crowell, Cardio Flow; Cassie Svendsen, Cardio Flow; Dr. Pradeep Nair; Jared LeBoeuf, RT; Shaneka Shoot, RT; and Toni Barrios, RN.

Dr. Pradeep Nair, M.D., an interventional cardiologist in Houma, LA, and a recognized leader in the treatment of PAD and critical limb-threatening ischemia, commented:

Dr. Pradeep Nair, M.D

“Peripheral arterial blockages are extremely common, especially in our patients with heart disease. This new technology allows us to treat a wide range of blockages effectively from the ankle to the hip, with the goal of saving limbs—and ultimately our patients’ lives and the quality of those lives.”

FreedomFlow’s Innovative, Modern Approach to Atherectomy

FreedomFlow’s dynamic atherectomy platform is the latest technological advancement for treating patients with PAD and restoring blood flow. Its catheter-based design uses diamond-coated spheres to sand the blockage, leveraging the physics of angular momentum to keep the spheres in constant contact with the vessel wall, whether the device is advancing or retracting. A diamond-coated tip likewise helps physicians ease the driveshaft through tight blockages.

FreedomFlow’s modern mechanism of action maximizes operational efficiency and reduces procedural run times, and its simplicity offers time savings and cost efficiencies for physicians and clinics, with quick and simple device setup no capital equipment, no lubricant, and reduced inventory needs. It also provides consistent treatment outcomes and a nearly flat learning curve for physicians, making it an ideal choice for today’s hospitals, ambulatory surgical centers, and office-based labs.

About Cardio Flow, Inc.

Cardio Flow, Inc., is a privately held medical device company located in St. Paul, MN, which designs and develops minimally invasive peripheral vascular products with the goal of providing physicians with better treatment options for peripheral vascular disease to improve patients’ lives.

See cardioflow.net for more information.

About Cardiovascular Institute of the South

The Cardiovascular Institute of the South (CIS) is a world leader in preventing, detecting, and treating cardiovascular and peripheral vascular disease, and has earned international acclaim as a pioneer of research, development, and education, as well as an innovator in the treatment of peripheral artery disease.

With a dedicated team of more than 1,075 members, CIS provides comprehensive cardiovascular care at 21 locations across Louisiana and Mississippi.

See cardio.com for more information.

Mailing address

Cardio Flow, Inc.
525 Main Street, Box 120018
St. Paul, MN 55112 USA

Physical address

Cardio Flow, Inc.
3530 88th Ave NE
Blaine, MN 55014 USA

The post Cardio Flow Announces Completion of First Commercial Cases appeared first on Cardio Flow, Inc..

FreedomFlow Orbital Atherectomy Platform Receives FDA 510(k) Clearance to Treat Peripheral Artery Disease

Andrew Luce — Tue, 17 Oct 2023 12:00:44 +0000

PRESS RELEASE | FOR IMMEDIATE RELEASE | Download press release

St. Paul, MN – October 18, 2023. Cardio Flow, Inc., a privately held medical device company and developer of minimally invasive devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the company’s FreedomFlow Orbital Atherectomy Peripheral Platform.

The FreedomFlow platform is designed with a modern mechanism of action to clear plaque blockages in the arteries of the legs. This proprietary, catheter-based design leverages the physics of angular momentum, creating a spiral geometry that puts five diamond-coated spheres in simultaneous contact with the vessel wall, whether advancing or retracting. A diamond-coated tip also helps ease the driveshaft through tight blockages.

This unique approach gives physicians a highly efficient, effective, and flexible way to treat complex PAD in a wide range of vessel diameters—from 2 mm in the ankle to 8 mm in the hip—and greater versatility in treating multiple arteries and multiple blockages in the same vessel, all with a single device.

The simplicity of the FreedomFlow platform likewise offers time savings and cost efficiencies, with quick and simple device setup, no capital equipment, no lubricant, and reduced inventory needs. It also provides faster run times, consistent treatment outcomes, and a nearly flat learning curve for physicians, making it an ideal choice for today’s hospitals, ambulatory surgical centers, and office-based labs.

Dr. Thomas Davis, M.D., the Director of Cardiovascular Research at Ascension St. John’s Hospital in Detroit, MI, and a recognized leader in the treatment of PAD and critical limb-threatening ischemia, commented:

Dr. Thomas Davis, M.D.

“The incidence of patients presenting with multi-level PAD has increased dramatically in my practice, so having a flexible, efficient, and easy-to-use device that can treat PAD in a broad range of vessel sizes is a key advantage for physicians and patients as we seek to reduce the number of PAD-related amputations.”

Michael J. Kallok, Ph.D., CEO of Cardio Flow, stated:

Michael J. Kallok, Ph.D.

“Cardio Flow is committed to providing meaningful solutions that directly address the needs of physicians and their PAD patients through innovative product development. Many of the existing atherectomy devices on the market have various design constraints and capital equipment costs.

With FreedomFlow, we strove to provide physicians with the freedom to treat complex PAD hip to heel with a simple yet sophisticated device that would answer the call for flexible treatment options and cost savings for healthcare systems. We’re excited that FreedomFlow will now be available to physicians.”

About Cardio Flow, Inc.

See cardioflow.net for more information.

About PAD

Peripheral Arterial Disease is a chronic circulatory condition that, if left untreated, can result in unnecessary limb amputations. In the United States, it’s estimated that 8 to 10 million individuals suffer from PAD annually. Critical Limb-Threatening Ischemia (CLTI), a more severe form of PAD, currently affects approximately 2 to 3 million people in the U.S. and is expected to exceed 4 million by 2030.

Rates of amputation have steadily been increasing in the U.S. over the past 20 years. In fact, the Amputation Reduction and Compassion (ARC) Act, introduced in Congress in June 2023, seeks to reduce the high rates of amputation in the U.S. via professional awareness, patient empowerment, and early diagnosis and care.

Sources: Mark A. Creager, et. al., “Reducing Nontraumatic Lower-Extremity Amputations by 20% by 2030: Time to get to Our Feet: A Policy Statement from the American Heart Association,” Circulation, 143:17, April 27, 2021; American Diabetes Association press release, “ADA Unveils Amputation Prevention Alliance to Address the Diabetes-Related Amputation Pandemic,” September 22, 2022; Mary L. Yost, “Critical Limb Ischemia: Volume 1. United States Epidemiology, 2016 Supplement,” The Sage Group, 2017; Jihad A. Mustapha, et. al., “Treatment of Peripheral Artery Disease and Critical Limb Ischemia: An Observational Michigan Medical Analysis,” Journal of Critical Limb Ischemia, 3:2, June 2023; Amputation Reduction and Compassion Act of 2023, H.R. 4216, 118th Cong. (2023). All sources accessed online in September 2023.

Contact:

Scott Kraus, VP Sales & Marketing
Cardio Flow, Inc.
Mobile: (610) 247-3173
Email: skraus@cardioflow.net

The post FreedomFlow Orbital Atherectomy Platform Receives FDA 510(k) Clearance to Treat Peripheral Artery Disease appeared first on Cardio Flow, Inc..

Cardio Flow, Inc., Announces FDA Clearance for FreedomFlow Peripheral Guidewire, plus First Commercial Case Completed in U.S.

Andrew Luce — Thu, 02 Jun 2022 21:40:39 +0000

PRESS RELEASE | FOR IMMEDIATE RELEASE | Download press release

St. Paul, MN – June 2, 2022 – Cardio Flow, Inc., a medical device company and developer of minimally invasive peripheral vascular devices to treat peripheral artery disease (PAD), today announced it recently received U.S. Food and Drug Administration (FDA) clearance for the company’s FreedomFlow® Peripheral Guidewire.

The FreedomFlow guidewire is stainless steel core-to-tip design with a fixed distal-spring coil which was developed to provide exceptional support for diagnostic and therapeutic devices used in treating plaque blockages in arteries both above and below the knee.

The new guidewire features a silicone-coated spring coil along with a silicone coating on the distal 200cm that eases the crossing of difficult blockages. Furthermore, the 0.014-inch core-to-tip design provides interventionists superior torque transmission and precise control when delivering therapeutic devices.

First Commercial Case

Dr. Jihad Mustapha, MD, FACC, FSCAI

This week Dr. Jihad Mustapha, MD, FACC, FSCAI, the Director of Endovascular Interventions at Advanced Cardiac & Vascular Centers for Amputation Prevention in Grand Rapids, MI, completed the first commercial case with the new guidewire on a patient presenting with complex multi-vessel disease with blockages below the knee, requiring a pedal loop.

Dr. Mustapha was impressed with the trackability and versatility of the FreedomFlow guidewire, noting,

I was able to deliver three PTA balloons, one IVUS catheter, and a therapeutic device across the single guidewire—all glided easily along the FreedomFlow wire. This new product has the potential to save time and costs in the endovascular lab, given its versatility in crossing occlusions and ability to deliver multiple interventional devices on a single guidewire.

Scott Kraus, Vice President of Sales & Marketing for Cardio Flow, commented: “Cardio Flow is encouraged by the initial feedback from Dr. Mustapha, who is a recognized leader in the treatment of PAD and critical limb ischemia (CLI). We look forward to bringing this advancement in guidewire technology to our U.S. customers with a limited market release, followed by expanded commercial efforts in 2022.”

FreedomFlow Peripheral Guidewire

About Cardio Flow, Inc.

Cardio Flow, Inc., is a privately held medical device company that develops minimally invasive peripheral vascular products. The FreedomFlow® Peripheral Guidewire is the first of several devices in development to treat Peripheral Artery Disease (PAD). See cardioflow.net for more information.

About Advanced Cardiac & Vascular Centers® (ACV)

Launched in February 2018, Advanced Cardiac & Vascular Centers for Amputation Prevention provides highly personalized and comprehensive cardiac, vascular, and vein care. Co-founded by Dr. Jihad Mustapha and Dr. Fadi Saab, ACV Centers has a special concentration on treating peripheral artery disease and the complications of critical limb ischemia. For further information, visit acvcenters.com.

Contact:

Scott Kraus, VP Sales & Marketing
Cardio Flow, Inc.
Tel: (610) 247-3173
Email: skraus@cardioflow.net

###

The post Cardio Flow, Inc., Announces FDA Clearance for FreedomFlow Peripheral Guidewire, plus First Commercial Case Completed in U.S. appeared first on Cardio Flow, Inc..