K Number
DEN240017
Device Name
ShortCut
Manufacturer
Date Cleared
2024-09-27

(163 days)

Product Code
Regulation Number
870.1254
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction.
Device Description
The ShortCut is a transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to transfemoral aortic valve replacement (TAVR), to reduce the risk of coronary ostium obstruction and coronary access compromise and enable a valve-in-valve procedure for patients at risk of coronary obstruction. Splitting of a leaflet creates a triangular opening in the leaflet that allows blood flow into the adjacent coronary artery. The ShortCut is a sterile, single use, 16 Fr device which is inserted through the femoral artery over a guidewire into the left ventricle using standard catheter placement techniques. The ShortCut is comprised of the following parts: - a. Distal Unit (DU) Distal end of the catheter which contacts the valve leaflets and splits them (Figure 1). It is comprised of the Splitting Element (SE) and the Positioning Arm (PA). The Splitting Element penetrates the leaflet from the ventricular side at the bottom of the leaflet and performs the cut. The Positioning Arm is positioned on the aortic aspect of the leaflet and acts as a protective stabilizer for the activated SE. The DU is delivered in a sheathed 16 Fr configuration that is opened upon reaching the target site. - b. Delivery System (DS) The catheter shafts connect the Handle to the DU and delivers the required movements from the Handle to the DU. The DS is compatible with a 16 Fr introducer sheath and is delivered over a 0.035" Guide Wire (GW). The outer shaft of the DS (Sheathing Tube) is used to sheathe the DU during introduction and removal from the body. The inner shafts of the DS. together with its pig-tailed tip, enable flexing and positioning of the DU at the valve. - c. Handle The user interface, designed to control the DS and the DU and to enable correct positioning of the DU on the valve (Figure 2).
More Information

Not Found

Not Found

No
The description focuses on the mechanical function of the device (splitting leaflets) and does not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Yes
The ShortCut device is designed to split bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures and reduce the risk of coronary obstruction, which directly impacts the treatment and management of a patient's medical condition.

No

The ShortCut is described as a "splitting device" designed to physically alter (split) bioprosthetic aortic valve leaflets, facilitating a medical procedure (valve-in-valve TAVR). Its purpose is to reduce the risk of coronary obstruction by creating an opening, not to diagnose a condition or provide information about a patient's health status.

No

The device description clearly outlines physical components such as a catheter, distal unit with a splitting element and positioning arm, a delivery system with shafts, and a handle. These are all hardware components, indicating it is not a software-only device.

Based on the provided information, the ShortCut device is not an In Vitro Diagnostic (IVD).

Here's why:

  • Intended Use: The intended use is to physically split bioprosthetic aortic valve leaflets in vivo (within the body) to facilitate a surgical procedure (valve-in-valve TAVR).
  • Device Description: The device is a transfemoral catheter designed for insertion into the body to perform a mechanical action (splitting).
  • Lack of IVD Characteristics: IVDs are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The ShortCut device does not perform any such analysis of biological specimens.

The ShortCut is a surgical/interventional device used directly on anatomical structures within the patient's body.

N/A

Intended Use / Indications for Use

ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction.

Product codes (comma separated list FDA assigned to the subject device)

SCZ

Device Description

The ShortCut is a transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to transfemoral aortic valve replacement (TAVR), to reduce the risk of coronary ostium obstruction and coronary access compromise and enable a valve-in-valve procedure for patients at risk of coronary obstruction. Splitting of a leaflet creates a triangular opening in the leaflet that allows blood flow into the adjacent coronary artery.

The ShortCut is a sterile, single use, 16 Fr device which is inserted through the femoral artery over a guidewire into the left ventricle using standard catheter placement techniques. The ShortCut is comprised of the following parts:

  • a. Distal Unit (DU) Distal end of the catheter which contacts the valve leaflets and splits them (Figure 1). It is comprised of the Splitting Element (SE) and the Positioning Arm (PA). The Splitting Element penetrates the leaflet from the ventricular side at the bottom of the leaflet and performs the cut. The Positioning Arm is positioned on the aortic aspect of the leaflet and acts as a protective stabilizer for the activated SE. The DU is delivered in a sheathed 16 Fr configuration that is opened upon reaching the target site.
  • b. Delivery System (DS) The catheter shafts connect the Handle to the DU and delivers the required movements from the Handle to the DU. The DS is compatible with a 16 Fr introducer sheath and is delivered over a 0.035" Guide Wire (GW). The outer shaft of the DS (Sheathing Tube) is used to sheathe the DU during introduction and removal from the body. The inner shafts of the DS. together with its pig-tailed tip, enable flexing and positioning of the DU at the valve.
  • c. Handle The user interface, designed to control the DS and the DU and to enable correct positioning of the DU on the valve (Figure 2).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Bioprosthetic aortic valve leaflets

Indicated Patient Age Range

at least 18 years of age

Intended User / Care Setting

physicians and/or surgeons trained and qualified in interventional cardiology procedures and that have carefully read and fully understand the IFU and have completed all training required by Pi-Cardia.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench Studies:
A series of bench tests were conducted to verify that the design met the functional specifications. These included tests for:

  • Tubing Strength
  • Positioning Stability - Compression Bond Test
  • Splitting Stability Bond Test
  • Handle Bond Strength
  • Tip Bond Strength
  • DU to Frame Tube bond
  • Torsional Strength
  • Corrosion*
  • Pushability Force
  • Sheathing / Unsheathing forces
  • Axial Splitting Force Repeatability
  • Flushing Test
  • Hydrophilic Coating integrity
  • Particulate Evaluation
  • Simulated Use (including compatibility with introducer sheath, guidewire, and connectors, correct penetration point, successful leaflet split, intact catheter markings, and catheter integrity)
  • Dimensional Verification
  • Deflection Verification Test
  • Leak Test
  • Sheathing with Blockage Verification*
  • Abort Splitting Verification*
  • Usability Data (Summative usability evaluation and design validation)
    *These characterization tests were performed on unaged devices only.
    Results: The engineering bench testing demonstrated acceptable performance of the device for its intended use. Overall, 90.0% of cases the first device split the leaflet and in 100% of cases the device was withdrawn successfully.

Animal Study:
Study Type: One in vivo GLP animal study.
Sample Size: 5 pigs.
Purpose: To evaluate the acute safety (per thrombogenicity and hemodynamic stability evaluations) and functionality (per leaflet split verification and usability evaluation) of the ShortCut device.
Design: In each animal, a ShortCut procedure was performed to split both the left and right coronary leaflets of the aortic valve. The study included assessment of device usability, visual inspection for thrombus formation, and gross pathology and histopathology examination.
Key Results: For usability assessment, all categories were scored at either 3 ('good and acceptable', 1 animal) or 4 ('very good and acceptable', 4 animals) for all procedures. Visual examination of the intervened leaflets showed that all target leaflets were successfully split. In general, no hemodynamic abnormalities were observed during the procedures, with one animal showing increased heart rate. No visible emboli or signs of ischemia were found in evaluated organs (heart, aorta, lungs, kidneys, liver, brain, spleen). Slight abrasions of the inner aortic walls were observed. Thrombus was not observed on the devices after removal from the animals.

Clinical Study (Pivotal Study - The ShortCut Study):
Study Type: Prospective, international, multi-center, non-randomized, single-arm, open-label pivotal study.
Sample Size: 60 subjects.
Data Source: 23 sites worldwide (13 US, 8 EU, 2 Israel).
Objective: To assess the safety and effectiveness of the ShortCut for splitting bioprosthetic aortic valve leaflets and to demonstrate coronary artery ostia patency following leaflet split, in subjects at risk for TAVR-induced coronary artery ostium obstruction following a valve-in-valve (ViV) TAVR procedure.
Key Results:

  • Primary Effectiveness Endpoint: Per-subject leaflet splitting success was achieved in 100% (60/60) of subjects by one of the two pre-defined methods (visualized split or increase in transvalvular AR) and was statistically significantly higher (p

N/A

0

DE NOVO CLASSIFICATION REQUEST FOR SHORTCUT

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures. This device is a single use percutaneous catheter system that has a cutting element on the distal end. The cutting element makes physical contact with target tissue to cut or split heart valve leaflets in a manner that may reduce obstructive flow complications with transcatheter valve procedures. The device is indicated for use immediately prior to a transcatheter valve procedure.

NEW REGULATION NUMBER: 21 CFR 870.1254

CLASSIFICATION: Class II

PRODUCT CODE: SCZ

BACKGROUND

DEVICE NAME: ShortCut

SUBMISSION NUMBER: DEN240017

DATE DE NOVO RECEIVED: May 1, 2024

SPONSOR INFORMATION: Pi-Cardia Ltd. 5 David Fikes St. Rehovot 7632805 Israel

INDICATIONS FOR USE

ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction.

LIMITATIONS

The sale, distribution, and use of the ShortCut Device are restricted to prescription use in accordance with 21 CFR 801.109.

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The ShortCut should only be used by physicians and/or surgeons trained and qualified in interventional cardiology procedures and that have carefully read and fully understand the IFU and have completed all training required by Pi-Cardia.

At the time of granting of this De Novo, the safety and effectiveness of ShortCut have been demonstrated only for splitting bioprosthetic aortic valve leaflets in patients undergoing a concomitant valve-in-valve procedure, and who are determined to be at high risk of coronary ostia obstruction.

PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The ShortCut is a transfemoral catheter designed to split the bioprosthetic aortic valve leaflets prior to transfemoral aortic valve replacement (TAVR), to reduce the risk of coronary ostium obstruction and coronary access compromise and enable a valve-in-valve procedure for patients at risk of coronary obstruction. Splitting of a leaflet creates a triangular opening in the leaflet that allows blood flow into the adjacent coronary artery.

The ShortCut is a sterile, single use, 16 Fr device which is inserted through the femoral artery over a guidewire into the left ventricle using standard catheter placement techniques. The ShortCut is comprised of the following parts:

  • a. Distal Unit (DU) Distal end of the catheter which contacts the valve leaflets and splits them (Figure 1). It is comprised of the Splitting Element (SE) and the Positioning Arm (PA). The Splitting Element penetrates the leaflet from the ventricular side at the bottom of the leaflet and performs the cut. The Positioning Arm is positioned on the aortic aspect of the leaflet and acts as a protective stabilizer for the activated SE. The DU is delivered in a sheathed 16 Fr configuration that is opened upon reaching the target site.
  • b. Delivery System (DS) The catheter shafts connect the Handle to the DU and delivers the required movements from the Handle to the DU. The DS is compatible with a 16 Fr introducer sheath and is delivered over a 0.035" Guide Wire (GW). The outer shaft of the DS (Sheathing Tube) is used to sheathe the DU during introduction and removal from the body. The inner shafts of the DS. together with its pig-tailed tip, enable flexing and positioning of the DU at the valve.
  • c. Handle The user interface, designed to control the DS and the DU and to enable correct positioning of the DU on the valve (Figure 2).

2

Image /page/2/Figure/0 description: The image shows a medical device with labels and measurements. The device is labeled as having a distal unit, a delivery system (16/14 Fr.), and a handle. The distal unit is 1150mm away from the start of the handle, and the handle is 600mm long. The handle has a diameter of 35mm.

Figure 1: The ShortCut Device

SUMMARY OF NONCLINICAL/BENCH STUDIES

Nonclinical studies conducted for the ShortCut device are summarized below.

| Classification | The ShortCut is considered an externally communicating device
that is intended to come in direct contact with circulating blood
for a limited duration (80%). Stroke or mortality rates in small ViV TAVR studies are reported at rates of 1.4% and 3.5%. respectively. Therefore, the study size is sufficient to observe stroke or mortality events for subjects receiving the ShortCut procedure within a 2-fold margin (i.e., 2.8%) of rates expected in ViV TAVR studies.

Accountability

A total of 137 subjects were screened for the study worldwide (US, Europe, and Israel). 66 of the 137 subjects were screening failures. 6 subjects dropped out of the study before treatment, and 5 subjects enrolled from OUS sites were considered not poolable by the conditions of the US protocol. Therefore, sixty (60) enrolled subjects were eligible for inclusion in the IDE Shortcut Pivotal study.

  • . There were multiple reasons for the 66 screening failures, including but not limited to: subject not as risk for TAVR-induced coronary artery obstruction, subject not planning to undergo percutaneous ViV procedure for an approved indication, excessive aortic valve leaflet calcium morphology, and/or unsuitable anatomy or condition for the device or procedure.

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  • · The 5 OUS subjects that did not meet the US eligibility criteria per the approved IDE clinical protocol were considered non-poolable for the following reasons:
    • · Planned provisional stent (2);
    • Coronary disease that should be treated or treatment of coronary disease =18 years old and recommended for an approved ViV TAVR indication. Patients were not suitable in cases of severe or moderate thickened and calcified aortic valve leaflets at the intended laceration site, or anatomy that would not allow safe placement of an embolic protection device. In addition, patients who had a cerebral vascular accident or transient ischemic attack in the 12 months prior to procedure were not approved.

Demographics

Subject demographics, baseline characteristics, and risk factors for coronary artery obstruction are presented in the Table 15, below:

| | n=8
n or mean $\pm$ SD |
|-----------------------------------------------------------------|---------------------------|
| Age, yr | $77.0 \pm 9.6$ |
| Male | 2 |
| Female | 6 |
| STS score, % | $6.6 \pm 4.5$ |
| NYHA Class | |
| I-II | 0 |
| III-IV | 8 |
| Left ventricular ejection fraction, % | $56 \pm 9$ |
| Failed Valve Type | |
| SAVR | 6 |
| TAVR | 2 |
| Failed Valve Disease | |
| Isolated aortic stenosis (AS) | 4 |
| Isolated aortic regurgitation (AR) | 1 |
| Mixed (AS and AR) | 3 |
| Risk factors for coronary obstruction (8 patients, 11 leaflets) | |
| Coronary height, mm | $7.7 \pm 3.8$ |
| Sinus of Valsalva width, mm | $27.2 \pm 5.6$ |
| Sinus of Valsalva height, mm | $15.6 \pm 7.0$ |
| VTC distance, mm | $2.9 \pm 0.7$ |
| VTS distance, mm | $2.9 \pm 0.8$ |

Table 15: Compassionate Use Patient Demographics, Baseline Characteristics, and Risk Factors for Coronary Obstruction

Clinical Results

Procedural Outcomes

The procedural outcomes of the compassion use cases are shown below.

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| Procedure Detail | n=8
n or mean ± SD |
|----------------------------------|-----------------------|
| Intervened Leaflet | |
| Left | 5 |
| Right | 0 |
| Left and right | 3 |
| Total procedure time* (min) | 141.1 ± 46.9 |
| ShortCutTM procedure time* (min) | 18.0 ± 5.9 |
| ViV TAVR procedure time* (min) | 11.0 ± 10.5 |
| Procedure Outcome – post TAVR | |
| Coronary obstruction | 0 |
| AR ≥ moderate AR | 0 |
| Mean gradient (mmHg) | 9.5 ± 3.7 |

Table 16: Summary of Procedural Outcomes & Results

Safety Outcomes

No serious adverse events (SAE) related to the ShortCut device or ShortCut procedure were reported for the 8 compassionate cases. All patients were discharged from the hospital in good condition and without coronary obstruction, stroke, or major complications. With follow-up between 15 to 18 months post-procedure, there were no reports of stroke or coronary obstruction.

Conclusions

The results from the first human experience in 8 reported compassionate use cases demonstrated that the ShortCut device and procedure is feasible to safely split one or two aortic bioprosthetic valve leaflets.

Pediatric Extrapolation

In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.

LABELING

The ShortCut labeling consists of Instructions for Use and packaging labels. The labeling satisfies the requirements of 21 CFR 801.109.

The Instructions for Use includes:

  • . Indications for Use;
  • Description of the device; .
  • Patient population the device has been demonstrated to be effective; .
  • . Contraindications, warnings, & precautions;
  • . Recommended training for safe use of the device;

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  • . Instructions for the safe use of the device, including the maximum number of cutting actions and deployments for each device and target site;
  • . Detailed summary of the clinical data collected in support of the device;
  • Prescription statement; .
  • Shelf life. .

Please see the Limitations section above for important warnings and precautions presented in the device labeling.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with heart valve leaflet splitting devices and the measures necessary to mitigate these risks.

Risks to HealthMitigation Measures
InfectionSterilization validation
Shelf life testing
Labeling
Adverse tissue reactionBiocompatibility evaluation
Incomplete valve tissue splittingClinical performance testing
In vivo performance testing
Non-clinical performance testing
Electrical safety testing
Electromagnetic compatibility testing
Shelf life testing
Labeling
Tissue injury: non-targeted tissue, vascular
injury, dissectionClinical performance testing
In vivo performance testing
Non-clinical performance testing
Electrical safety testing
Electromagnetic compatibility testing
Labeling
Embolic events: thromboembolic, e.g. ; stroke;
bioprosthetic embolism; device embolismClinical performance testing
In vivo performance testing
Biocompatibility evaluation
Non-clinical performance testing
Shelf life testing
Labeling
Blood flow obstructionClinical performance testing
In vivo performance testing
Interaction with cardiac conduction system
leading to postoperative arrythmias, including
atrial fibrillation and heart blockClinical performance testing
In vivo performance testing
Labeling

Table 17: Identified Risks to Health and Mitigation Measures

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SPECIAL CONTROLS

In combination with the general controls of the FD&C Act, the percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures is subject to the following special controls:

  • (1) Clinical performance testing of the device must demonstrate that the device performs as intended under anticipated conditions of use. Testing must evaluate:
    • (i) The ability to safely deliver and remove the device;
    • (ii) Performance in cutting or splitting of the target valve leaflets;
    • Compatibility with concomitant transcatheter valve procedures; and (iii)
    • All adverse events observed, including device malfunctions, tissue or vascular injury, (iv) hemodynamic abnormalities, embolic events, cerebrovascular adverse events, and unanticipated surgical interventions.
  • (2) In vivo performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be assessed:
    • (i) Delivery, use, and retrieval of the device:
    • (ii) Cutting or splitting of target leaflet(s); and
    • Gross pathology and histopathology assessing leaflet splitting, soft tissue damage, (iii) and downstream embolization.
  • (3) Non-clinical performance testing data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
    • (i) Simulated use testing in a clinically relevant bench anatomic model to assess feasibility of device operation under worst-case clinical conditions, including device delivery, use, retrieval, and compatibility with accessory devices via transcatheter approach:
    • (ii) Consistency and reliability of cutting action;
    • Ability to advance and position the device to reach the target site: (iii)
    • (iv) Mechanical integrity testing (e.g., bond/joint strength, torsional strength) of the device under anticipated loading conditions;
    • Assessment of material-specific risks, such as corrosion if the device contains metal (v) components, or coating integrity and particulates if the device contains lubricious coatings: and
    • Characterization and verification of critical dimensions. (vi)
  • (4) Compatibility testing for devices that contain electrical components must include:
    • Electrical safety and electromagnetic compatibility (EMC) testing: and (i)
    • Software verification, validation, and hazard analysis for all devices that contain (ii) software.
  • (5) All patient-contacting components of the device must be demonstrated to be biocompatible.

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  • (6) Performance data must demonstrate the sterility of the device components intended to be provided sterile.
  • (7) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the labeled shelf life.
  • (8) Labeling must include the following:
    • The recommended training for safe use of the device; (i)
    • Information on the patient population for which the device has been demonstrated to (ii) be effective;
    • (iii) Identification of the maximum number of cutting actions and deployments for each device and for each target site; and
    • (iv) A detailed summary of the clinical testing conducted; and
    • (v) A shelf life.

BENEFIT-RISK DETERMINATION

The ShortCut device is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction. In general, the risks of ShortCut are expected to be similar to those observed with transcatheter cardiac devices and procedures.

The probable risks of the device are based on nonclinical laboratory and/or animal studies, as well as data collected in a clinical study described above. There are known difficulties and risks associated with ShortCut that are inherent to transcatheter heart valve procedures, and which are outlined below:

  • Aortic regurgitation .
  • Cardiovascular injury including perforation or dissection of vessels, aorta, ventricles, . myocardium or valvular structures that may require intervention
  • Conduction system disturbance or injury which may require a permanent pacemaker .
  • . Cardiogenic shock
  • Coronary ostium obstruction .
  • . Embolization including air. calcific valve material or thrombus
  • . Hematoma or hemorrhage requiring transfusion or intervention
  • . Infection including septicemia and endocarditis, pneumonia
  • . Myocardial infarction
  • . Pain or bleeding at the access site
  • . Pericardial tamponade
  • Acute kidney injury .
  • Stroke or transient ischemic attack .
  • . Death

Clinical investigation of ShortCut for splitting bioprosthetic aortic valve leaflets to facilitate valve-in-valve procedures for patients at risk of coronary obstruction demonstrated 0% mortality

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through discharge or 7-day follow-up period. Three (3) deaths were reported occurring through the 90-day follow-up period which were determined non-cardiovascular related to the ShortCut device or procedure. There was one (1) disabling stroke reported, which was adjudicated as not related to the ShortCut device, possibly related to ShortCut procedure, and definitely related to the overall ViV procedure. Through the 90-dav follow-up, there were 114 adverse events reported in the study cohort (91 events adjudicated per protocol as 40 serious adverse events (SAE) and 51 adverse events (AE)). Overall, the adverse events reported in the clinical study are anticipated events for transcatheter cardiac procedures. As the ShortCut procedure is performed concomitant with TAVR, isolating events and risks specific to ShortCut is confounded; however, the frequency of adverse events reported in the clinical study, including death and stroke, are at rates that are expected and reasonable for a patient population undergoing ViV TAVR. Therefore, ShortCut does not add new or different clinical risks, nor does it exacerbate the risks inherent with transcatheter cardiac procedures.

The probable benefits of the device are also based on nonclinical laboratory and/or animal studies, as well as data collected in a clinical study described above. Probable benefits of the device are based on demonstration that ShortCut performs reliably and effectively in splitting the targeted aortic leaflet(s) on a failed bioprosthetic valve in preparation for ViV TAVR. Nonclinical and animal studies demonstrated the device met all design specifications and achieved repeatable leaflet cutting. In the clinical study, the primary effectiveness endpoint of per-subject leaflet splitting success was achieved in all subjects (100%) with only one technical failure (98.3% technical success). The clinical study was not statistically powered to demonstrate subsequent clinical benefit of leaflet splitting; however, it can be reasonably expected that successful leaflet splitting will provide the following benefits:

  • · Provide ViV TAVR as a treatment option for patients at high risk of coronary obstruction who may otherwise be denied treatment or undergo risky surgical procedures:
  • . Reduce occurrence of coronary obstruction compared to the expected rates in the high-risk target population.

All subjects enrolled and treated in the clinical study were determined to be at high risk of coronary artery ostia obstruction in the context of ViV TAVR and the clinical outcomes were favorable with use of ShortCut to facilitate ViV TAVR. Partial or complete coronary artery obstruction was noted in 3 subjects (5%) despite use of ShortCut. Of these subjects, no mortality or significant change in LV function occurred throughout study duration. Further, all three patients were successfully managed using standard percutaneous coronary intervention technique without surgical bailout. Overall, the reported 5% coronary obstruction and subject outcomes in the ShortCut Study compare favorably to reported rates of coronary artery ostia obstruction and related-mortality in patients at high-risk of coronary obstruction undergoing ViV TAVR without ShortCut assistance.

Additional factors to be considered in determining probable risks and benefits for the ShortCut include: limitations of the ShortCut Pivotal Study; that the ShortCut is intended to be used concomitant with TAVR procedure; and that the treatment principle of splitting aortic valve leaflets to facilitate a TAVR procedure has been validated in clinical practice. Limitations of the submitted clinical study are that the study was designed to analyze sixty (60) subjects with

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primary endpoints assessed no later than 7 days post-index procedure. The study cohort had low racial and ethnic diversity. The study was powered for an effectiveness endpoint of functional performance: vet, the study was not designed to statistically determine clinical effectiveness or powered to assess the primary safety endpoint. While identifying adverse events or risks specific to ShortCut is confounded by concomitant TAVR, it is not expected that use of ShortCut will increase the risks of the TAVR procedure. Moreover, the treatment principle of ShortCut is similar to that validated in the BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction during TAVR) procedure and study, which also splits aortic valve leaflets but using a different cutting modality. Therefore, clinical outcomes with BASILICA may be leveraged to address certain limitations of the ShortCut Study, as listed above.

Overall. the known or probable risks are considered not to be meaningfully different than risks associated with other transcatheter cardiac procedures. When considering the totality of evidence, there is a reasonable expectation that ShortCut will provide an effective treatment option for patients at risk of coronary obstruction when undergoing a valve-in-valve procedure.

Patient Perspectives

This submission did not include specific information on patient perspectives for this device.

Benefit/Risk Conclusion

In conclusion, given the available information, the probable benefits outweigh the probable risks of ShortCut for the following indication statement:

The ShortCut is indicated for use as a splitting device of bioprosthetic aortic valve leaflets to facilitate valve procedures for patients at risk of coronary obstruction.

The device provides benefits and the risks can be mitigated by the use of general controls and the identified special controls.

CONCLUSION

The De Novo request for ShortCut is granted and the device is classified as follows:

Product Code:SCZ
Device Type:Percutaneous catheter for cutting or splitting heart valve leaflets
concomitant to transcatheter valve procedures
Regulation:21 CFR 870.1254
Class:II