Tag: IVL

Updated SCAI Guidance Includes Coronary IVL as a Treatment Option in All U.S. Catheterization Labs Regardless of Surgical Backup Status

Guidance Expands Number of Hospitals that Can Access IVL to Include Sites Where Calcium Modification Tools Were Previously Not Recommended SANTA CLARA, Calif., Jan. 31, 2023 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced that coronary IVL was […]

Shockwave Medical Initiates All-Female Coronary IVL Study

EMPOWER CAD is the First Prospective, Female-Only Study of Coronary Interventions Study Seeks to Confirm Benefits of Shockwave’s Coronary IVL in Females Who Historically Have Suffered Less Favorable Clinical Outcomes than Male Patients with Traditional Therapies SANTA CLARA, Calif., Sept. 19, 2022 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy […]

Shockwave Medical and Genesis MedTech Obtain Regulatory Approval in China for Intravascular Lithotripsy

Approvals Cover Both Coronary and Peripheral IVL Catheters and Generators Manufactured by Shockwave SANTA CLARA, Calif. and SINGAPORE, May 23, 2022 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, and Genesis MedTech Group announced today that they have successfully obtained approval […]

Shockwave IVL Coronary Studies Demonstrate Excellent PCI Outcomes in Both Women and Men at One Year

Findings Hold Promise for Female Patients with Calcified Coronary Artery Disease Who Previously Suffered Worse Safety Outcomes than Male Patients Undergoing Atherectomy SANTA CLARA, Calif., May 19, 2022 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today new data […]

Cardiovascular Systems, Inc. Announces Development of Intravascular Lithotripsy Technology for the Treatment of Coronary and Peripheral Artery Diseases

Complementary technology to orbital atherectomy expands CSI’s vessel prep market opportunity ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today it has made significant progress towards the commercialization of intravascular lithotripsy (IVL) systems for […]

Shockwave Medical Unveils First One-Year Results of Coronary Intravascular Lithotripsy

New Data at TCT From the Disrupt CAD Clinical Program Demonstrate Consistency of Shockwave IVL Outcomes Over Time, Across Calcium Morphologies and Between Genders November 05, 2021 08:00 ET | Source: Shockwave Medical, Inc. SANTA CLARA, Calif., Nov. 05, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) […]

Publications Validate Clinical Safety and Efficacy of Shockwave Intravascular Lithotripsy

Simultaneous Publication of Three Studies in the Journal of the American College of Cardiology: Cardiovascular Interventions SANTA CLARA, Calif., June 28, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the safety, efficacy and mechanism of benefit […]

CMS Grants Transitional Pass-Through (TPT) Payment for Shockwave’s Coronary IVL

Provides Incremental Reimbursement in Hospital Outpatient Setting SANTA CLARA, Calif., June 11, 2021 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Centers for Medicare & Medicaid Services (CMS) granted approval for a Transitional Pass-Through (TPT) payment for Shockwave C2 Coronary IVL device, effective July […]

Shockwave Announces Decisions From the U.S. Patent and Trademark Office on Inter Partes Review Proceeding

SANTA CLARA, Calif., July 08, 2020 (GLOBE NEWSWIRE) — Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease, announced today that the company received the initial rulings related to two of the inter partes review (IPR) cases that were initiated by Cardiovascular Systems, Inc. (CSI). In […]