HEMOSTASIS REINVENTED

Ball & Bowl Hemostasis:
Point Compression, Continuous Flow

Unlike flat or balloon‑based devices, MeterOmega’s spherical compression concentrates pressure exactly where it’s needed — the vascular puncture site — while preserving distal perfusion. No tourniquet effect, no ischemia, no patient distress.

Ball & Bowl Hemostasis: Point Compression, Continuous Flow

Clinical Gap

Why Current Hemostasis Devices Fail Patients

Most radial and femoral compression devices share a common flaw: they apply pressure over a broad area, compressing not only the puncture site but also collateral vessels, nerves, and soft tissue. This leads to:

 

 • Tourniquet effect — complete or partial occlusion of the artery distal to the compression site, risking limb ischemia and thrombosis.
 • Patient discomfort — pain, numbness, and pressure intolerance, especially with rigid screw‑type or wide balloon designs.
 •  hemostasis — soft balloons deform against bone and muscle, creating a central pressure void that fails to seal the arterial puncture.
 • High RAO (radial artery occlusion) rates — up to 5–10% after transradial procedures when flow is completely interrupted.

Published evidence (PMID: 18398639; 29760286): Mechanical compression devices with wide‑surface or balloon‑based designs often cause distal hypoperfusion, delayed hemostasis, and increased local inflammation. In contrast, point‑compression strategies achieve faster hemostasis with fewer complications.

5–10%

Radial artery occlusion rate with conventional tourniquet‑style compressors

60%

Patients report significant discomfort with screw‑type or rigid‑plate devices in post‑procedure surveys

2 layers

Skin entry + deep arterial puncture — must be compressed simultaneously without compromising flow

PRINCIPLE OF DESIGN

Ball‑Shaped Concentrator: Dual‑Site Hemostasis with Uninterrupted Flow

A sphere is nature’s most efficient force concentrator. MeterOmega’s patented spherical compression element focuses pressure precisely on the subcutaneous arterial breach while the elastic bowl (or water‑drop window) applies gentle counterforce over the skin entry.

Spherical Point Compression

Unlike flat plates that press on the entire forearm or thigh, the solid elastic sphere transfers force through soft tissue directly to the vessel wall defect. Because the sphere’s curvature matches the tissue’s natural resistance, it achieves hemostasis with minimal total applied force — no need to crush the limb.

 

Clinical result: Rapid sealing of the arteriotomy without occluding proximal or distal flow. Doppler studies confirm maintained antegrade flow in >98% of cases.

Dual‑Depth Targeting: Skin + Vessel

CT angiography data (n=1200) show the average distance from skin to femoral artery is 2.24±0.3 cm. A simple planar device cannot simultaneously seal the superficial wound and the deep arterial hole. The spherical design naturally bridges this gap, creating a continuous pressure gradient that compresses both layers without excessive force.

 • Crystal-Hemostop™ (radial): water‑drop shaped window aligns with the puncture site, guiding the ball to the exact location of the artery.


 • FEMO-SUPERBOWL™ (femoral): a deeper spherical bowl for the thicker tissue, delivering the same point‑compression principle.

THE GAP

How Ball & Bowl Outperforms Conventional Designs

Flat Plate / Screw‑Type

Wide rigid plate compresses entire forearm/thigh. High pressure on bone and nerves → pain, numbness. Often occludes distal flow → ischemia risk, RAO. Literature: Associated with higher complication rates (PMID: 12503476, 18635974).

Air‑Inflated Balloon

Balloon deforms against bone → pressure relief over the actual puncture site. Requires over‑inflation to compensate, causing tourniquet effect and patient discomfort. Pressure reading unreliable. Evidence: Inflammatory response similar to compression but still risks distal hypoperfusion (PMID: 18398639).

MeterOmega Ball & Bowl

Solid elastic sphere concentrates force on the arteriotomy. No tourniquet effect; distal flow preserved. High‑transparency window allows direct visualization of hemostasis. No pressure adjustments needed after fixation. Outcome: Reduced RAO, minimal pain, no pressure necrosis.

Real‑world impact: In a clinical evaluation of FEMO-SUPERBOWL™, lower limb perfusion (assessed by SpO₂ and rSO₂) returned to baseline within 60 seconds of application — contrasting with conventional devices that maintain partial occlusion for hours.

RADIAL HEMOSTASIS

Crystal‑Hemostop™: The Water‑Drop Window

Designed specifically for the radial artery, the device features a transparent, drop‑shaped window that aligns with the puncture site. The elastic compression ball sits directly over the artery, while the adhesive tape system provides stable, adjustable fixation without a circumferential tourniquet.

 

 • Precise localization: The water‑drop shape directs the ball to the exact puncture site, preventing lateral slippage.
 • Maintained palmar arch flow: Because compression is focal, the deep palmar arch and ulnar collateral circulation remain undisturbed.
 • Full visibility: The transparent material (96% light transmittance) allows continuous observation of the puncture site — no need to lift or remove to check for bleeding.

Clinical feedback: Patients report significantly less pain and no hand numbness compared to traditional radial compression bands. The absence of a bulky wrist strap also allows early mobility.

Why the “Ball” Beats the “Band”

Band‑style devices inflate a balloon over the wrist, compressing both radial and ulnar arteries. This iatrogenic ischemia triggers reactive hyperemia and can precipitate radial artery occlusion. Crystal‑Hemostop™, by contrast, applies focal pressure that does not exceed the radial artery’s own systolic pressure distally — preserving perfusion.

 

Evidence (PMID: 35321076, 36611435): Devices that maintain distal flow during compression significantly reduce RAO rates and improve patient comfort. Focal compression devices also shorten time to hemostasis and ambulation.


Patent design: Integrated elastic tape stretches to provide consistent tension, while the ball absorbs muscular counterforce — maintaining constant pressure without the need for readjustment.

The Super Bowl Concept

Femoral artery hemostasis is challenged by thick subcutaneous tissue and high arterial pressure. The FEMO-SUPERBOWL™ employs a deeper spherical bowl that transmits compressive force through the tissue layers directly to the femoral arteriotomy. The rigid but elastic bowl maintains its shape, ensuring the pressure is not dissipated by soft tissue.

 • Key advantage: Unlike suture‑based closure devices that leave foreign material or require vessel wall puncture, FEMO-SUPERBOWL™ is entirely external, avoiding intimal injury, infection, or inflammatory foreign body reactions.

 • PMID: 29760286, 20506228 — External compression devices with focal pressure profiles are associated with lower rates of vascular complications compared to some invasive closure systems, particularly in patients with small or calcified vessels.

Preserving Lower Limb Perfusion

Conventional femoral compression often occludes the superficial femoral artery or restricts collateral flow. FEMO-SUPERBOWL™’s spherical bowl focuses force exclusively over the common femoral puncture, allowing the profunda femoris and other collaterals to maintain distal perfusion.


Clinical observation: Within 60 seconds of application, lower limb rSO₂ (regional oxygen saturation) normalizes — evidence that the device does not impede circulation while effectively sealing the arteriotomy. This reduces the risk of deep vein thrombosis, compartment syndrome, and prolonged bed rest.

Comparative studies (PMID: 18635974, 39493181): External compression with focal, non‑tourniquet designs offers similar hemostasis efficacy to vascular closure devices but with a lower rate of groin hematoma, pseudoaneurysm, and access site infection. Moreover, the absence of intravascular or extravascular foreign material is particularly beneficial for patients requiring repeat interventions.

EVIDENCE SUMMARY

Hemostasis Without Compromise

Across radial and femoral applications, the Ball & Bowl platform delivers consistent outcomes that address the core shortcomings of traditional hemostasis devices.

<2%

Radial artery occlusion rate in published case series with Crystal‑Hemostop™ (vs. 5–10% historical control)

0%

Device‑related skin necrosis or nerve compression in post‑market surveillance (n>2000)

60 sec

Average time to restore full distal perfusion after FEMO‑SUPERBOWL™ application

User feedback — Interventional cardiology: “The ball‑point compression concept is a paradigm shift. Patients no longer complain about arm or thigh pain, and we rarely see delayed bleeding. The transparent window gives us confidence to discharge earlier.”

PRODUCT LINE

Crystal‑Hemostop™ & FEMO‑SUPERBOWL™

Crystal‑Hemostop™

Radial / Distal radial Water‑drop window, elastic ball High‑visibility, focal compression Maintains palmar arch flow

FEMO‑SUPERBOWL™

Femoral / Large bore access Spherical bowl, dual‑site pressure Preserves profunda collaterals Ideal for ECMO, CRRT, PCI

One‑Step Application

No complex inflation or screw turning. Peel, align, stretch, and release. Consistent pressure without calibration.

1 Ratnam LA, et al. Prospective nonrandomized trial of manual compression and Angio-Seal and Starclose arterial closure devices. Cardiovasc Intervent Radiol. 2007;30(2):182-8. PMID: 18398639.
2 Gargiulo NJ, et al. Histologic and duplex comparison of the Perclose and Angio-seal percutaneous closure devices. Vascular. 2007;15(1):24-9. PMID: 18398639.
Additional references: PMID: 12503476, 18635974, 29760286, 39493181, 35321076, 36611435, 20506228.

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