Editor's Note: It was suggested that a useful addition to this site would be an update on recent US Food & Drug Administration (FDA) decisions related to cardiovascular devices. This is the first such update. Comments or suggestions are appreciated.

Approvals

Medtronic Riptide Aspiration System Approval

The Riptide Aspiration System (Medtronic, Dublin, Ireland) was approved for the endovascular revascularization of acute ischemic stroke secondary to intracranial large vessel occlusions including the M1 and M2 carotid systems and the vertebral system. The device is indicated for patients who are ineligible for intravenous tissue plasminogen activator (tPA) presenting within 8 hours of symptom onset or who have failed tPA. This direct aspiration device adds to existing devices for aspiration thrombectomy as a treatment for acute stroke treatment.¹

Abiomed Receives Expanded Indications for Impella 2.5, CP, 5.0, and LD Devices

Acute and chronic cardiomyopathy with shock. The FDA extended the indication of Impella (Abiomed; Danvers, MA) temporary heart support for additional classes of severe left ventricular (LV) failure. Specifically included are acute myocarditis, peripartum cardiomyopathy, and other forms of cardiomyopathy with shock that failed standard treatment. The devices are intended for short-term use: 4 days for the 2.5 and CP devices and 6 days for the 5.0 and LD devices. This extends the use in severe decompensated LV dysfunction, which was initially approved for management of cardiogenic shock associated with acute myocardial infarction and for post-cardiotomy syndromes. Data supporting the expanded indications were derived from the cVAD Registry Impella experience.²

High-risk percutaneous coronary intervention. The FDA has given an expanded indication for Impella support for high-risk percutaneous coronary intervention. Previously, the indication was restricted to complex vascular anatomy and clinically high-risk patients and included depressed LV function. The expanded indication no longer includes the specific additional need for severe LV dysfunction. Thus, patients are considered at risk, Impella candidates based on complex coronary anatomy with significant comorbidities independent of LV function. This reflects data from the cVAD Registry indicating that most high-risk patients are surgical turndowns and exhibit significant acute procedure risk regardless of baseline LV function.³

Abiomed Granted Pre-Market Approval for SmartSensor Technology on Impella CP to Aide in Positioning and Hemodynamic Assessments

Abiomed announced that the FDA has approved its pre-market approval request for SmartAssist technology on the Impella CP for the improved management of cardiogenic shock. The technology consists of an optical sensor that will aid in real-time positioning of the device and provide hemodynamic measurements from the catheter sensor, providing immediate LV pressure, LV end diastolic pressure, and cardiac power output). These additions should provide more immediate hemodynamics to guide patient care. The console has also been upgraded to achieve a 15% decrease in set-up time. The goals of these advancements are to provide rapid and optimized cardiac support to improve the speed and effectiveness of Impella support in the setting of cardiogenic shock. The device has CE Marking in Europe. Data provided to the FDA for approval review included more than 60 cases from 3 centers (2 in the United States). These advancements will be integrated into selected centers across the United States based on their experience and protocols for myocardial recovery.⁴

FDA Extends the Use of Stryker Trevo Clot Retriever Device

The Trevo XP ProVue Retriever (Stryker; Kalamazoo, MI) has received an extended indication. It is currently approved for clot extraction in patients with acute stroke who have failed tPA or are not candidates for tPA and are within 6 hours of the onset of the event. The FDA has now extended the applicable time up to 24 hours from event onset. This change is based on data from two recent trials, DAWN (DWI or CTP Assessment With Clinical Mismatch in the Triage of Wake-Up and Late Presenting Strokes Undergoing Neurointervention With Trevo) and DEFUSE 3 (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke), demonstrating a clinical benefit for late reperfusion up to 24 hours post event onset. The FDA responded to trial data showing that at 3 months, patients treated with the Trevo device plus medical treatment had a 48% chance of major recovery compared with only 13% of patients treated only with medications. Risks associated with device use remain unchanged, as do methods of use except for the time window.^5,6

Medtronic 2.0 mm Resolute Onyx Drug-Eluting Stent Coronary Stent Approved

Described in a press release⁷ as the first stent approved for vessels <2.25 mm, the Resolute Onyx 2.0 (Medtronic, Dublin, Ireland) approval is based on a recent multicenter study⁸ of 101 patients (104 lesions) with a mean reference vessel diameter of 1.91 mm treated with the Resolute Onyx stent. One-year follow-up revealed target lesion failure of 5.0% with a target lesion revascularization rate of 2.0%. Binary restenosis was 12%. Myocardial infarction occurred in 3%, with no stent thrombosis reported. The principle investigator of the trial, Dr. Matthew J. Price, notes in the press release that the stent is highly deliverable and can be post-dilated to 3.5 mm, making it potentially useful in difficult-to-access lesions. Medtronic describes the drug-eluting stent as having a crossing profile of less than 1.0 mm, supporting the claim of a high rate of deliverability.

Warnings

FDA Issues a Warning for Zoll LifeVest 4000

An FDA warning⁹ for the external Zoll LifeVest (ZOLL Medical Corporation; Pittsburgh, PA) wearable cardioverter-defibrillator indicates that the device in certain circumstances might not perform appropriately by failing to deliver appropriate therapy for a potentially fatal arrhythmia. The device apparently indicates that the user should call ZOLL for service under "Code 102," but the message does not indicate the urgency of the problem, nor the fact that the device is not protective at that time. The LifeVest has been widely used for over 17 years. The FDA reports the Code 102 warning has occurred in approximately 0.1% of the over 33,000 devices distributed worldwide, including 24,975 devices distributed in the United States. The FDA reports that one fatality has occurred because of the messaging failure.⁹

FDA Expedited Device Approval

In response to the concern that the United States is often behind other countries in the approval of break-through cardiovascular devices, the FDA had previously launched the Early Feasibility Studies (EFS) program. Although slow in initial rollout, 2017 has seen an increasing use of this program to introduce new devices in a more rapid fashion. The program utilizes the investigational device exemption (IDE) regulations to grant early approval. The EFS program offers investigators, clinicians, sponsors, and the FDA to work collaboratively in beginning feasibility studies often before exact indications, safety, and even optimal characteristics are clear. The program offers a significant opportunity for small startups to optimize development with less dollar investment.

The FDA emphasizes that the regulatory flexibility in the program provides an opportunity for the risk benefit to be assessed without putting patients at unnecessary risk.

Today, FDA's Center for Devices and Radiological Health has an EFS program that provides a route for innovators, sponsors, FDA review teams, and clinicians to work together to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations.

The program was originally approved in late 2013 but was promoted in 2013 and 2014, resulting in earlier US clinical studies. IDEs have increased yearly, with 57 submitted in 2017. Importantly, during the first 2 years of the program, 75% of IDEs have been approved or approved with conditions during the 30-day review cycle. The FDA emphasizes that the process requires effective collaboration between the investigators/sponsors and the FDA.¹⁰

References

1. Medtronic Receives FDA Clearance for Riptide(TM) Aspiration System (Medtronic website). January 16, 2018. Available at http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2326781. Accessed 04/02/2018.
2. Abiomed Receives Approval for Expanded FDA Indication for Cardiomyopathy with Cardiogenic Shock (Abiomed website). February 13, 2018. Available at http://investors.abiomed.com/news-releases/news-release-details/abiomed-receives-approval-expanded-fda-indication-cardiomyopathy. Accessed 04/02/2018.
3. Abiomed Receives Approval for Expanded FDA Indication for High Risk Percutaneous Coronary Intervention (PCI) Procedures (Abiomed website). February 14, 2018. Available at http://investors.abiomed.com/news-releases/news-release-details/abiomed-receives-approval-expanded-fda-indication-high-risk-0. Accessed 04/02/2018.
4. Abiomed Receives FDA Approval for Impella CP® with SmartAssist™ and Optical Sensor (Abiomed website). April 2, 2018. Available at http://investors.abiomed.com/news-releases/news-release-details/abiomed-receives-fda-approval-impella-cpr-smartassisttm-and. Accessed 04/02/2018.
5. FDA expands treatment window for use of clot retrieval devices in certain stroke patients (FDA website). February 15, 2018. Available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596983.htm. Accessed 04/02/2018.
6. Powers WJ, Rabinstein AA, Ackerson T, et al. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018;49: e46-e110.
7. Medtronic Launches First 2.0 mm Drug-Eluting Stent in United States Designed to Treat Patients with Small Vessels (Medtronic website). February 26, 2018. Available at http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2334596. Accessed 04/02/2018.
8. Price MJ, Saito S, Shlofmitz RA, et al. First Report of the Resolute Onyx 2.0-mm Zotarolimus-Eluting Stent for the Treatment of Coronary Lesions With Very Small Reference Vessel Diameter. JACC Cardiovasc Interv 2017;10:1381-8.
9. US Food and Drug Administration. Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - Potential Lack of Treatment (Shock) Delivery Due to Device Failure: FDA Safety Communication (FDA website). January 17, 2018. Available at https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm592583.htm. Accessed 04/02/2018.
10. Dreher ML A, Faris O. Bringing Early Feasibility Studies for Medical Devices Back to the United States (FDA website). December 12, 2017. Available at https://blogs.fda.gov/fdavoice/index.php/2017/12/bringing-early-feasibility-studies-for-medical-devices-back-to-the-united-states/. Accessed 04/02/2018.

Keywords: United States Food and Drug Administration, Tissue Plasminogen Activator, Shock, Cardiogenic, Research Personnel, Cytidine Triphosphate, Drug-Eluting Stents, Stroke, Feasibility Studies, Triage, Myocarditis, Blood Pressure, Brain Ischemia, Peripartum Period, Device Approval, Myocardial Infarction, Thrombectomy, Registries, Percutaneous Coronary Intervention, Thrombosis, Arrhythmias, Cardiac, Defibrillators, Comorbidity, Radiologic Health, Patient Care

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